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slow recruitment
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The goal of this study is determine if an oral systemic course of steroids is a safe and effective option in lowering pain and complications following adenotonsillectomy in various pediatric age groups. A double blind, placebo-controlled randomized clinical trial of steroids (dexamethasone) versus placebo postoperatively will be performed. Investigators will determine if there is a difference in post-operative pain and complications between groups.
Purpose: To determine if post-operative dexamethasone is a safe and effective option in the reduction of post-operative pain and morbidity following adenotonsillectomy in various pediatric age groups.
Methods: The subject population will be patients between the ages of 3 and 17 who will undergo adenotonsillectomy. The study will consist of two double-blinded arms - patients receiving a course of oral dexamethasone (doses on post-operative days 2, 4, and 6; 0.5 mg/kg; max dose: 20 mg) in addition to standard pain control regimen and patients receiving an oral placebo course in addition to standard pain control regimen. In the diary they will receive, patients or caregivers will record when specific pain medications were taken each day, a symptoms survey, and pain ratings measured by the Wong-Baker FACES Pain Rating Scale. Patients are able to return their diary at a post-operative appointment at CHP Main, through email by scanning the diary or taking pictures with their phone, or through mailing in the survey in a pre-stamped envelope. Demographic information such as age, race, gender, and household income will be extracted from the diary and the electronic medical record. Information such as surgical technique, concurrent operations, post-operative pain prescription (types, weight based dosage, and total days prescribed) will be extracted from the electronic medical record and recorded as well. Outcomes measured will include pain scale rating and rates of complications between the two groups.
Significance: If it can be demonstrated that dexamethasone after adenotonsillectomy can reduce pain, complications, or need for opioid analgesics without appreciable side effects, a strong argument can be made for the addition of this inexpensive medication to routine post-operative adenotonsillectomy care. This would help with limiting the burden of clinical course of tonsillectomy.
The primary and secondary outcome measures were refined prior to analysis. Originally, the primary outcome measure was "average pain burden" defined as "average pain over 14 post-operative days before and after medications." However, study medication was not administered until day 2, and the power analysis was based on a study by Palme et al (2000) that compared mean pain ratings on postoperative days 2-8. Therefore, the primary outcome was revised to "average pain over 2-8 post-operative days before medications." Average pain over 2-8 post-operative after medications was added as a secondary outcome. The original primary outcome combined analysis of pain before and after medication into one measure. However, pain scores were more commonly reported prior to medication than after. Due to missing post-medication scores, it was determined that the analysis would be more appropriately conducted separately for pain scores before and after medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone | Experimental | IV Dexamethasone Sodium Phosphate will be prescribed orally at a dose of 0.5mg/kg with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The Dexamethasone will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital. |
|
| Placebo | Placebo Comparator | An equal volume of water will be prescribed to patients (0.5mg/kg) with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The placebo (water) will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | IV Dexamethasone Sodium Phosphate will be prescribed orally at a dose of 0.5mg/kg with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The Dexamethasone will be mixed by the parents with 5mL of pre-packaged cherry syrup |
| Measure | Description | Time Frame |
|---|---|---|
| Average Pain Over 2-8 Post-operative Days Before Medications | Average pain over 2-8 post-operative days before medications. This is quantified using the validated Wong-Baker FACES pain metric. The scale is from 0 to 10 with 10 being worse outcome. Patients receive a take-home pain diary and for 14 days report their maximum pain both before and after taking each pain medication. The mean of the pain ratings prior to taking pain medications from post-operative days 2-8 will be the primary outcome measure. | 2-8 days post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| ED (Emergency Department) or Urgent Care Visits | Number of emergency department or urgent care visits in 30 post-operative days - assessed via the electronic medical record and the take-home pain diary. | 30 days post-operatively |
| Average Pain Burden Post-medication |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Readmissions | Number of hospitalizations after discharge in 30 days - assessed using the electronic medical record and the take-home pain diary. | 30 days post-operatively |
| Frequency of Each Analgesic Used |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David H. Chi, MD | Clinical Director, Division of Pediatric Otolaryngology, UPMC Children's Hospital of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States | ||
| Children's Hospital North Surgery Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23392233 | Background | Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3. | |
| 30585626 | Background | Whelan RL, McCoy J, Mirson L, Chi DH. Opioid prescription and postoperative outcomes in pediatric patients. Laryngoscope. 2019 Jun;129(6):1477-1481. doi: 10.1002/lary.27614. Epub 2018 Dec 26. |
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Only co-investigators as listed under the University of Pittsburgh IRB (Institutional Review Board) protocol for this study will have access to all data and analysis. Data will be shared via UPMC-associated OneDrive and will only be shared between these investigators.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone | IV Dexamethasone Sodium Phosphate will be prescribed orally at a dose of 0.5mg/kg with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The Dexamethasone will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital. |
| FG001 | Placebo | An equal volume of water will be prescribed to patients (0.5mg/kg) with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The placebo (water) will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Excludes patients withdrawn due to protocol violation and physician decision
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone | IV Dexamethasone Sodium Phosphate will be prescribed orally at a dose of 0.5mg/kg with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The Dexamethasone will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Pain Over 2-8 Post-operative Days Before Medications | Average pain over 2-8 post-operative days before medications. This is quantified using the validated Wong-Baker FACES pain metric. The scale is from 0 to 10 with 10 being worse outcome. Patients receive a take-home pain diary and for 14 days report their maximum pain both before and after taking each pain medication. The mean of the pain ratings prior to taking pain medications from post-operative days 2-8 will be the primary outcome measure. | Includes only patients who returned their pain diary (completed the study). | Posted | Mean | 95% Confidence Interval | score on a scale | 2-8 days post-operatively |
|
5-9 weeks depending on the date of the follow-up appointment
Number at risk excludes patients withdrawn due to protocol violations or physician decision. These patients were instructed not to administer any study medication. One of these patients had surgery cancelled after consent was obtained.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexamethasone | IV Dexamethasone Sodium Phosphate will be prescribed orally at a dose of 0.5mg/kg with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The Dexamethasone will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-Tonsillectomy Hemorrhage Requiring Operative Intervention | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-Tonsillectomy Hemorrhage Requiring Neither Operative Intervention nor Inpatient Admission | Injury, poisoning and procedural complications | Systematic Assessment |
Early termination due to slow recruitment in older cohorts (8-12 and 13-17-year-olds) leading to small numbers of subjects analyzed in those age groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amber Shaffer | UPMC Children's Hospital of Pittsburgh | 4126926874 | shafferad@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 26, 2023 | Jul 2, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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Double blind placebo controlled randomized clinical trial
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| Ibuprofen | Drug | Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language. |
|
| Acetaminophen | Drug | Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language. |
|
| Placebo | Drug | An equal volume of water will be prescribed to patients (0.5mg/kg) with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The placebo (water) will be mixed by the parents with 5mL of pre-packaged cherry syrup. |
|
Average pain over 2-8 post-operative days after medications. This is quantified using the validated Wong-Baker FACES pain metric. The scale is from 0 to 10 with 10 being worse outcome. Patients receive a take-home pain diary and for 14 days report their maximum pain both before and after taking each pain medication. The mean of the pain ratings one hour after talking pain medications from post-operative days 2-8 will be a secondary outcome measure. |
| 2-8 days post-operatively |
In the take-home pain diary, patients will place an 'x' on each time block every day that medication was given for each of the three medications. The frequencies will be summed for a total number and averaged within each group to determine the average number of times of each analgesic used.
| 14 days post-operatively |
| Duration of Each Analgesic Used | Using the results of the take-home pain diary, the average number of days of use of each analgesic for each group will be calculated. The last day after which there is no subsequent use of analgesic will define the end-point of the duration of use. | 14 days post-operatively |
| Pain Relief Satisfaction | Score assigned by the patient at the end of 14 post-operative days in the take-home pain diary using a 5-point Likert scale of 0 (strongly disagree) to 4 (strongly agree). Patients will respond to the following statement "I am happy with the pain relief I received in the last 14 days" with responses ranging from strongly agree to strongly disagree. The responses will be assigned a numerical value and the average value for all subjects in the group will be reported as the overall pain relief satisfaction. Higher scores indicate a better outcome. | 14 days post-operatively |
| Frequency of Request for Opioid Medication | Number of requests for opioid medication in 14 post-operative days - assessed via the electronic medical record and the take-home pain diary. | 14 days post-operatively |
| Frequency of Post-operative Oropharyngeal Bleed | Number of post-operative oropharyngeal bleeds in 30 post-operative days - assessed via the electronic medical record. | 30 days post-operatively |
| Need for Follow-up Appointment | Does the parent/guardian believe his/her child would require a follow-up appointment - assessed using the individual pain diary. | Two months post-operatively |
| Household Income | Total household income ranges will be assessed in the take-home pain diary and reported. | 14 days post-operatively |
| Education Level | Using the take-home pain diary, parents/guardians of the patients will identify the highest level of education achieved by anyone in the household. | 14 days post-operatively |
| Side Effects of Medications | Number of side effects assessed daily including bleeding from mouth or throat, anxiety, difficulty breathing, nausea or vomiting, stomach pain/discomfort, fever (100.4F and higher) | 14 days post-operatively |
| Night-time Awakenings | Number of night-time awakenings reported in 14 days - assessed via the take-home pain diary. | 14 days post-operatively |
| Post-operative Nursing Phone Calls | Number of post-operative phone calls to nursing staff, obtained using the electronic medical record up to 30 days post-operatively. | 30 days post-operatively |
| Duration of Hospital Admission | Number of days in the hospital after surgery in 30 post-operative days - assessed via the electronic medical record | 30 days post-operatively |
| Sewickley |
| Pennsylvania |
| 15143 |
| United States |
| 31377901 | Background | Borgstrom A, Nerfeldt P, Friberg D. Postoperative pain and bleeding after adenotonsillectomy versus adenotonsillotomy in pediatric obstructive sleep apnea: an RCT. Eur Arch Otorhinolaryngol. 2019 Nov;276(11):3231-3238. doi: 10.1007/s00405-019-05571-w. Epub 2019 Aug 3. |
| 30448929 | Background | Titirungruang C, Seresirikachorn K, Kasemsuwan P, Hirunwiwatkul P. The use of steroids to reduce complications after tonsillectomy: a systematic review and meta-analysis of randomized controlled studies. Eur Arch Otorhinolaryngol. 2019 Feb;276(2):585-604. doi: 10.1007/s00405-018-5202-2. Epub 2018 Nov 17. |
| 22585378 | Background | Macassey E, Dawes P, Taylor B, Gray A. The effect of a postoperative course of oral prednisone on postoperative morbidity following childhood tonsillectomy. Otolaryngol Head Neck Surg. 2012 Sep;147(3):551-6. doi: 10.1177/0194599812447776. Epub 2012 May 14. |
| 29573428 | Background | Redmann AJ, Maksimoski M, Brumbaugh C, Ishman SL. The effect of postoperative steroids on post-tonsillectomy pain and need for postoperative physician contact. Laryngoscope. 2018 Sep;128(9):2187-2192. doi: 10.1002/lary.27167. Epub 2018 Mar 24. |
| 33228459 | Background | Greenwell AG, Isaiah A, Pereira KD. Recovery After Adenotonsillectomy-Do Steroids Help? Outcomes From a Randomized Controlled Trial. Otolaryngol Head Neck Surg. 2021 Jul;165(1):83-88. doi: 10.1177/0194599820973250. Epub 2020 Nov 24. |
| 20003121 | Background | Garra G, Singer AJ, Taira BR, Chohan J, Cardoz H, Chisena E, Thode HC Jr. Validation of the Wong-Baker FACES Pain Rating Scale in pediatric emergency department patients. Acad Emerg Med. 2010 Jan;17(1):50-4. doi: 10.1111/j.1553-2712.2009.00620.x. Epub 2009 Dec 9. |
| 11129008 | Background | Palme CE, Tomasevic P, Pohl DV. Evaluating the effects of oral prednisolone on recovery after tonsillectomy: a prospective, double-blind, randomized trial. Laryngoscope. 2000 Dec;110(12):2000-4. doi: 10.1097/00005537-200012000-00003. |
| 29215370 | Background | Feinberg AE, Chesney TR, Srikandarajah S, Acuna SA, McLeod RS; Best Practice in Surgery Group. Opioid Use After Discharge in Postoperative Patients: A Systematic Review. Ann Surg. 2018 Jun;267(6):1056-1062. doi: 10.1097/SLA.0000000000002591. |
| 29189368 | Background | Monitto CL, Hsu A, Gao S, Vozzo PT, Park PS, Roter D, Yenokyan G, White ED, Kattail D, Edgeworth AE, Vasquenza KJ, Atwater SE, Shay JE, George JA, Vickers BA, Kost-Byerly S, Lee BH, Yaster M. Opioid Prescribing for the Treatment of Acute Pain in Children on Hospital Discharge. Anesth Analg. 2017 Dec;125(6):2113-2122. doi: 10.1213/ANE.0000000000002586. |
| Lost to Follow-up |
|
| BG001 | Placebo | An equal volume of water will be prescribed to patients (0.5mg/kg) with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The placebo (water) will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI Percentile at Baseline | Median | Full Range | percentile |
|
| OG001 | Placebo | An equal volume of water will be prescribed to patients (0.5mg/kg) with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The placebo (water) will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital. |
|
|
|
| Secondary | ED (Emergency Department) or Urgent Care Visits | Number of emergency department or urgent care visits in 30 post-operative days - assessed via the electronic medical record and the take-home pain diary. | Excludes patients withdrawn due to protocol violations or physician decision. | Posted | Count of Participants | Participants | 30 days post-operatively |
|
|
|
|
| Secondary | Average Pain Burden Post-medication | Average pain over 2-8 post-operative days after medications. This is quantified using the validated Wong-Baker FACES pain metric. The scale is from 0 to 10 with 10 being worse outcome. Patients receive a take-home pain diary and for 14 days report their maximum pain both before and after taking each pain medication. The mean of the pain ratings one hour after talking pain medications from post-operative days 2-8 will be a secondary outcome measure. | Includes only patients who returned their pain diary (completed the study). One patient in the placebo group reported no post-medication pain scores. | Posted | Median | Full Range | score on a scale | 2-8 days post-operatively |
|
|
|
|
| Other Pre-specified | Number of Readmissions | Number of hospitalizations after discharge in 30 days - assessed using the electronic medical record and the take-home pain diary. | Not Posted | 30 days post-operatively | Participants |
| Other Pre-specified | Frequency of Each Analgesic Used | In the take-home pain diary, patients will place an 'x' on each time block every day that medication was given for each of the three medications. The frequencies will be summed for a total number and averaged within each group to determine the average number of times of each analgesic used. | Not Posted | 14 days post-operatively | Participants |
| Other Pre-specified | Duration of Each Analgesic Used | Using the results of the take-home pain diary, the average number of days of use of each analgesic for each group will be calculated. The last day after which there is no subsequent use of analgesic will define the end-point of the duration of use. | Not Posted | 14 days post-operatively | Participants |
| Other Pre-specified | Pain Relief Satisfaction | Score assigned by the patient at the end of 14 post-operative days in the take-home pain diary using a 5-point Likert scale of 0 (strongly disagree) to 4 (strongly agree). Patients will respond to the following statement "I am happy with the pain relief I received in the last 14 days" with responses ranging from strongly agree to strongly disagree. The responses will be assigned a numerical value and the average value for all subjects in the group will be reported as the overall pain relief satisfaction. Higher scores indicate a better outcome. | Not Posted | 14 days post-operatively | Participants |
| Other Pre-specified | Frequency of Request for Opioid Medication | Number of requests for opioid medication in 14 post-operative days - assessed via the electronic medical record and the take-home pain diary. | Not Posted | 14 days post-operatively | Participants |
| Other Pre-specified | Frequency of Post-operative Oropharyngeal Bleed | Number of post-operative oropharyngeal bleeds in 30 post-operative days - assessed via the electronic medical record. | Not Posted | 30 days post-operatively | Participants |
| Other Pre-specified | Need for Follow-up Appointment | Does the parent/guardian believe his/her child would require a follow-up appointment - assessed using the individual pain diary. | Not Posted | Two months post-operatively | Participants |
| Other Pre-specified | Household Income | Total household income ranges will be assessed in the take-home pain diary and reported. | Not Posted | 14 days post-operatively | Participants |
| Other Pre-specified | Education Level | Using the take-home pain diary, parents/guardians of the patients will identify the highest level of education achieved by anyone in the household. | Not Posted | 14 days post-operatively | Participants |
| Other Pre-specified | Side Effects of Medications | Number of side effects assessed daily including bleeding from mouth or throat, anxiety, difficulty breathing, nausea or vomiting, stomach pain/discomfort, fever (100.4F and higher) | Not Posted | 14 days post-operatively | Participants |
| Other Pre-specified | Night-time Awakenings | Number of night-time awakenings reported in 14 days - assessed via the take-home pain diary. | Not Posted | 14 days post-operatively | Participants |
| Other Pre-specified | Post-operative Nursing Phone Calls | Number of post-operative phone calls to nursing staff, obtained using the electronic medical record up to 30 days post-operatively. | Not Posted | 30 days post-operatively | Participants |
| Other Pre-specified | Duration of Hospital Admission | Number of days in the hospital after surgery in 30 post-operative days - assessed via the electronic medical record | Not Posted | 30 days post-operatively | Participants |
| 0 |
| 105 |
| 3 |
| 105 |
| 5 |
| 105 |
| EG001 | Placebo | An equal volume of water will be prescribed to patients (0.5mg/kg) with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The placebo (water) will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital. | 0 | 108 | 8 | 108 | 10 | 108 |
| Post-Tonsillectomy Hemorrhage with Inpatient Admission but Not Requiring Operative Intervention | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Dehydration Requiring Inpatient Admission | Metabolism and nutrition disorders | Systematic Assessment |
|
|
| Emergency Department Visit for Post-Operative Pain | General disorders | Systematic Assessment |
|
| Emergency Department Visit for Post-Operative Nausea or Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Surgical Site Infection | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| 2 ED or Urgent Care Visits |
|
| 3 ED or Urgent Care Visits |
|