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Single-center, randomized, open-label, non-inferiority treatment pilot study to evaluate the effectiveness of a combined acetaminophen and ibuprofen regimen for treatment of post-operative tonsillectomy pain in the pediatric population. 100 children undergoing tonsillectomy will be randomized to receive either a combined acetaminophen and ibuprofen regimen dosed every 6 hours or an alternating regimen of acetaminophen and ibuprofen dosed every 3 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alternating Regimen | Active Comparator | A regimen of acetaminophen and ibuprofen alternating doses every 3 hours. |
|
| Combined Regimen | Active Comparator | A regimen of acetaminophen and ibuprofen dosed together every 6 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alternating Acetaminophen and Ibuprofen | Drug | Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 3 | The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 from POD 1 through POD 3 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2. | up to 3 days following consent |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With FLACC Pain Scores ≥7 on Each Individual POD 1, 3, and 7 | The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 on each individual POD 1, 3, and 7 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30798778 | Background | Mitchell RB, Archer SM, Ishman SL, Rosenfeld RM, Coles S, Finestone SA, Friedman NR, Giordano T, Hildrew DM, Kim TW, Lloyd RM, Parikh SR, Shulman ST, Walner DL, Walsh SA, Nnacheta LC. Clinical Practice Guideline: Tonsillectomy in Children (Update). Otolaryngol Head Neck Surg. 2019 Feb;160(1_suppl):S1-S42. doi: 10.1177/0194599818801757. | |
| 26436644 |
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Eligible candidates scheduled to undergo tonsillectomy at SLCH were approached either in the outpatient setting or preoperative holding area prior to surgery by the study team. Recruitment period was from 3/2020 - 10/2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alternating Regimen | A regimen of acetaminophen and ibuprofen alternating doses every 3 hours. Alternating Acetaminophen and Ibuprofen: Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours. |
| FG001 | Combined Regimen | A regimen of acetaminophen and ibuprofen dosed together every 6 hours. Combined Acetaminophen and Ibuprofen: Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alternating Regimen | A regimen of acetaminophen and ibuprofen alternating doses every 3 hours. Alternating Acetaminophen and Ibuprofen: Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours. |
| BG001 | Combined Regimen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 3 | The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 from POD 1 through POD 3 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2. | Posted | Number | participants | up to 3 days following consent |
|
Adverse event data was collected post operatively days 1 through 7
Follow up surveys to assess pain scores and adverse events were sent to participants twice a day on post-operative day (POD) 1, 3, and 7.
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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 | Alternating Regimen | A regimen of acetaminophen and ibuprofen alternating doses every 3 hours. Alternating Acetaminophen and Ibuprofen: Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Leonard, MD, Principal Investigator | Washington University School of Medicine | 314-454-2136 | dsleonard@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 10, 2021 | Jul 9, 2024 | Prot_SAP_ICF_005.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D014069 | Tonsillitis |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Single-center, randomized, open-label, non-inferiority treatment pilot study
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Open-label
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| Combined Acetaminophen and Ibuprofen | Drug | Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours. |
|
|
| 3 separate individual days, will be completed days after the surgery |
| Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 7 | The proportion of cumulative FLACC pain scores ≥7 from POD 1 through POD 7 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2. | up to 7 days following consent |
| Number of Participants With Faces Pain Scores ≥8 on POD 1, 3, and 7 | The proportion of Faces pain scores ≥8 on POD 1, 3, and 7 compared between the combined and the alternating medication regimens. The Faces scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain. | 3 separate individual days, will be completed days after the surgery |
| Number of Participants With Cumulative Faces Pain Scores ≥8 From POD 1 Through POD 7 | The proportion of cumulative Faces pain scores ≥8 from POD 1 through POD 7 compared between the combined and the alternating medication regimens. The Faces scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain. | up to 7 days following consent |
| Number of Participants With Rescue Medication Usage Through POD 3 | The proportion of rescue medication usage from POD 1 through POD 3 compared between the combined and the alternating medication regimens. | up to 3 days following consent |
| Number of Participants With Rescue Medication Usage Through POD 7 | The proportion of rescue medication usage from POD 1 through POD 7 compared between the combined and the alternating medication regimens. | up to 7 days following consent |
| Proportion of Subjects That Adhere to the Assigned Medication Regimen | Proportion of subjects that adhere to the assigned medication regimen compared between the combined and the alternating medication regimens as determined by the medication log that the participants return at the end of the study. | up to 3 days following consent |
| Adverse Events | Incidence of adverse events | up to 7 days following consent |
| Ingram DG, Friedman NR. Toward Adenotonsillectomy in Children: A Review for the General Pediatrician. JAMA Pediatr. 2015 Dec;169(12):1155-61. doi: 10.1001/jamapediatrics.2015.2016. |
| Background | National Prospective Tonsillectomy Audit Final Report. Royal College of Surgeons https://www.rcseng.ac.uk/library-and-publications/rcs-publications/docs/tonsillectomy-audit/ |
| 28607888 | Background | Alvarez Palacios I, Gonzalez-Orus Alvarez-Morujo R, Alonso Martinez C, Ayala Mejias A, Arenas Britez O. Postoperative Pain in Adult Tonsillectomy: Is There Any Difference Between the Technique? Indian J Otolaryngol Head Neck Surg. 2017 Jun;69(2):187-193. doi: 10.1007/s12070-017-1058-9. Epub 2017 Jan 16. |
| 25241379 | Background | Lauder G, Emmott A. Confronting the challenges of effective pain management in children following tonsillectomy. Int J Pediatr Otorhinolaryngol. 2014 Nov;78(11):1813-27. doi: 10.1016/j.ijporl.2014.08.011. Epub 2014 Aug 27. |
| 27647717 | Background | Tobias JD, Green TP, Cote CJ; SECTION ON ANESTHESIOLOGY AND PAIN MEDICINE; COMMITTEE ON DRUGS. Codeine: Time to Say "No". Pediatrics. 2016 Oct;138(4):e20162396. doi: 10.1542/peds.2016-2396. Epub 2016 Sep 19. |
| 25624387 | Background | Kelly LE, Sommer DD, Ramakrishna J, Hoffbauer S, Arbab-Tafti S, Reid D, Maclean J, Koren G. Morphine or Ibuprofen for post-tonsillectomy analgesia: a randomized trial. Pediatrics. 2015 Feb;135(2):307-13. doi: 10.1542/peds.2014-1906. |
| Background | Ismail Zaidan & Amanda Lent. Post-Tonsillectomy Pain in Children: The Postcodeine Era. US Pharm. 41, 31-34 (2016). |
| 26164211 | Background | D'Souza JN, Schmidt RJ, Xie L, Adelman JP, Nardone HC. Postoperative nonsteroidal anti-inflammatory drugs and risk of bleeding in pediatric intracapsular tonsillectomy. Int J Pediatr Otorhinolaryngol. 2015 Sep;79(9):1472-6. doi: 10.1016/j.ijporl.2015.05.042. Epub 2015 Jul 2. |
| 23881651 | Background | Lewis SR, Nicholson A, Cardwell ME, Siviter G, Smith AF. Nonsteroidal anti-inflammatory drugs and perioperative bleeding in paediatric tonsillectomy. Cochrane Database Syst Rev. 2013 Jul 18;2013(7):CD003591. doi: 10.1002/14651858.CD003591.pub3. |
| 20007794 | Background | Merry AF, Gibbs RD, Edwards J, Ting GS, Frampton C, Davies E, Anderson BJ. Combined acetaminophen and ibuprofen for pain relief after oral surgery in adults: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):80-8. doi: 10.1093/bja/aep338. |
| 16480830 | Background | Miranda HF, Puig MM, Prieto JC, Pinardi G. Synergism between paracetamol and nonsteroidal anti-inflammatory drugs in experimental acute pain. Pain. 2006 Mar;121(1-2):22-8. doi: 10.1016/j.pain.2005.11.012. Epub 2006 Feb 9. |
| 16970023 | Background | Gardiner P, Dvorkin L. Promoting medication adherence in children. Am Fam Physician. 2006 Sep 1;74(5):793-8. |
| 8709739 | Background | Haynes RB, McKibbon KA, Kanani R. Systematic review of randomised trials of interventions to assist patients to follow prescriptions for medications. Lancet. 1996 Aug 10;348(9024):383-6. doi: 10.1016/s0140-6736(96)01073-2. |
| 30572868 | Background | Uitti JM, Salantera S, Laine MK, Tahtinen PA, Ruohola A. Adaptation of pain scales for parent observation: are pain scales and symptoms useful in detecting pain of young children with the suspicion of acute otitis media? BMC Pediatr. 2018 Dec 20;18(1):392. doi: 10.1186/s12887-018-1361-y. |
A regimen of acetaminophen and ibuprofen dosed together every 6 hours. Combined Acetaminophen and Ibuprofen: Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
A regimen of acetaminophen and ibuprofen dosed together every 6 hours. Combined Acetaminophen and Ibuprofen: Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours. |
|
|
| Secondary | Number of Participants With FLACC Pain Scores ≥7 on Each Individual POD 1, 3, and 7 | The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 on each individual POD 1, 3, and 7 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2. | Posted | Number | participants | 3 separate individual days, will be completed days after the surgery |
|
|
|
| Secondary | Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 7 | The proportion of cumulative FLACC pain scores ≥7 from POD 1 through POD 7 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2. | Posted | Number | participants | up to 7 days following consent |
|
|
|
| Secondary | Number of Participants With Faces Pain Scores ≥8 on POD 1, 3, and 7 | The proportion of Faces pain scores ≥8 on POD 1, 3, and 7 compared between the combined and the alternating medication regimens. The Faces scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain. | Posted | Number | participants | 3 separate individual days, will be completed days after the surgery |
|
|
|
| Secondary | Number of Participants With Cumulative Faces Pain Scores ≥8 From POD 1 Through POD 7 | The proportion of cumulative Faces pain scores ≥8 from POD 1 through POD 7 compared between the combined and the alternating medication regimens. The Faces scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain. | Posted | Number | participants | up to 7 days following consent |
|
|
|
| Secondary | Number of Participants With Rescue Medication Usage Through POD 3 | The proportion of rescue medication usage from POD 1 through POD 3 compared between the combined and the alternating medication regimens. | Posted | Number | participants | up to 3 days following consent |
|
|
|
| Secondary | Number of Participants With Rescue Medication Usage Through POD 7 | The proportion of rescue medication usage from POD 1 through POD 7 compared between the combined and the alternating medication regimens. | Posted | Number | participants | up to 7 days following consent |
|
|
|
| Secondary | Proportion of Subjects That Adhere to the Assigned Medication Regimen | Proportion of subjects that adhere to the assigned medication regimen compared between the combined and the alternating medication regimens as determined by the medication log that the participants return at the end of the study. | Posted | Count of Participants | Participants | up to 3 days following consent |
|
|
|
| Secondary | Adverse Events | Incidence of adverse events | Alternating regimen | Posted | Number | participants | up to 7 days following consent |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 3 |
| 25 |
| EG001 | Combined Regimen | A regimen of acetaminophen and ibuprofen dosed together every 6 hours. Combined Acetaminophen and Ibuprofen: Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours. | 0 | 25 | 0 | 25 | 3 | 25 |
| Emesis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bloody Oral Secretions | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pain - Uncontrolled | General disorders | Non-systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |