Not provided
Not provided
Not provided
Not provided
Not provided
Difficulty with enrollment
Not provided
Not provided
Not provided
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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
| University of Tennessee | OTHER |
Not provided
Not provided
Not provided
Prospective randomized controlled trial to determine if opioid-free anesthetic for tonsillectomy is non-inferior to standard opioid-containing anesthetic
Objectives:
Primary: To determine if an opioid-free anesthetic provides equivalent acute postoperative pain relief in tonsillectomy.
Secondary: To determine if post-operative pain at home is not significantly different with an opioid-free regimen compared to an opioid containing regimen for tonsillectomy.
Study Design: Prospective, randomized, multi-center trial study
Study Interventions and Measures:
Subject will be randomized to 1:1 intra-operative opioid-free (OFG) vs traditional care anesthetic with opioids (TCG) group
The primary endpoint is the median pain score (calculated by a blinded validated observer in the recovery room at two time intervals) between the two cohorts.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Care Group (TCG) | Active Comparator | Traditional anesthetic with opioids group will receive institutional standard clinical care for tonsillectomy, including a standardized opioid dose at the beginning of the case and again at the end if needed. Dexmedetomidine and Ketorolac will not be used intra-operatively in this cohort to prevent confounding. |
|
| Opioid-Free Group (OFG) | Experimental | Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean FLACC (Face, Legs, Activity, Cry, Consolability) Pain Score | Mean FLACC pain assessment scores are calculated 15 and 30 minutes after awakening, Scores are calculated by a blinded study team observer. Minimum Score: 0 and Maximum Score: 10. Higher scores indicate worse outcomes. One Nursing Maximum FLACC pain score is obtained by an unblinded patient Registered Nurse (RN) during the patient's Post-Anesthesia Care Unit (PACU) stay within one hour of awakening. The pain score is collected from the nursing documentation in the electronic medical record. FLACC Minimum Score: 0 and Maximum Score: 10 Higher scores indicate worse outcomes. | up to 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Nausea, Vomiting, Pruritis | Collected in recovery room and asked in questionnaires, collected from parents on post-operative days 1, 5, and 30. | up to post-op day 30 |
| Number of Participants Who Sought Unplanned Medical Attention |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tori Sutherland, MD,MPH | Children's Hospital of Philadelphia | Principal Investigator |
| Anthony Sheyn, MD, FACS | University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States | ||
| University of Tennessee Health Science Center; St. Jude Children's Research Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30516809 | Background | Volkow ND, Jones EB, Einstein EB, Wargo EM. Prevention and Treatment of Opioid Misuse and Addiction: A Review. JAMA Psychiatry. 2019 Feb 1;76(2):208-216. doi: 10.1001/jamapsychiatry.2018.3126. | |
| 30605448 | Background | Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. Drug and Opioid-Involved Overdose Deaths - United States, 2013-2017. MMWR Morb Mortal Wkly Rep. 2018 Jan 4;67(5152):1419-1427. doi: 10.15585/mmwr.mm675152e1. |
| Label | URL |
|---|---|
| Key substance use and mental health indicators in the United States: Results from the 2016 National Survey on Drug Use and Health (HHS Publication No. SMA 17-5044). Center f | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Traditional Care Group (TCG) | Traditional anesthetic with opioids group will receive institutional standard clinical care for tonsillectomy, including a standardized opioid dose at the beginning of the case and again at the end if needed. Dexmedetomidine and Ketorolac will not be used intra-operatively in this cohort to prevent confounding. Morphine: Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care. Fentanyl: Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care. |
| FG001 | Opioid-Free Group (OFG) | Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac. Ketorolac: Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis. Dexmedetomidine: Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Traditional Care Group (TCG) | Traditional anesthetic with opioids group will receive institutional standard clinical care for tonsillectomy, including a standardized opioid dose at the beginning of the case and again at the end if needed. Dexmedetomidine and Ketorolac will not be used intra-operatively in this cohort to prevent confounding. Morphine: Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care. Fentanyl: Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| 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 | Mean FLACC (Face, Legs, Activity, Cry, Consolability) Pain Score | Mean FLACC pain assessment scores are calculated 15 and 30 minutes after awakening, Scores are calculated by a blinded study team observer. Minimum Score: 0 and Maximum Score: 10. Higher scores indicate worse outcomes. One Nursing Maximum FLACC pain score is obtained by an unblinded patient Registered Nurse (RN) during the patient's Post-Anesthesia Care Unit (PACU) stay within one hour of awakening. The pain score is collected from the nursing documentation in the electronic medical record. FLACC Minimum Score: 0 and Maximum Score: 10 Higher scores indicate worse outcomes. | Nurse maximum pain score not documented for 2 subjects | Posted | Mean | Standard Deviation | score on a scale | up to 1 hour |
|
Up to 30 days
Definitions of adverse and/or serious adverse events do not differ from clinicaltrials.gov
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Traditional Care Group (TCG) | Traditional anesthetic with opioids group will receive institutional standard clinical care for tonsillectomy, including a standardized opioid dose at the beginning of the case and again at the end if needed. Dexmedetomidine and Ketorolac will not be used intra-operatively in this cohort to prevent confounding. Morphine: Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care. Fentanyl: Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prolonged admission | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oxygen Desaturation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
Early termination leading to small numbers of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tori Nicole Sutherland MD MPH | The Children's Hospital of Philadelphia | 443-631-5032 | sutherlant@chop.edu |
Not provided
| 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 | May 25, 2021 | Feb 28, 2024 | Prot_SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 17, 2023 | Feb 28, 2024 | ICF_005.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014069 | Tonsillitis |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| D020927 | Dexmedetomidine |
| D009020 | Morphine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Subject will be randomized to 1:1 intra-operative opioid-free (OFG) vs traditional care anesthetic with opioids (TCG) group.
Not provided
Not provided
The unblinded members are the treating anesthesiologist for the case, staff who randomize, and collect and enter intra-op medications into electronic data capture (EDC).
Blinded members include the subject/family members, the surgeon, staff who perform post-op assessment, physician investigator who perform any adverse event/serious adverse event (AE/SAE) assessments, statistician and data safety monitoring board (DSMB).
| Dexmedetomidine | Drug | Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure. |
|
|
| Morphine | Drug | Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care. |
|
| Fentanyl | Drug | Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care. |
|
Number of participants who were readmitted to the hospital and sought unplanned medical attention (phone calls, office visits, emergency department visits) by chart review and questionnaires for readmission and medical reattendance, including calls to physician |
| up to post-op day 30 |
| Number of Participants Who Were Readmitted to the the Hospital | Number of participants who were readmitted to the hospital by chart review and questionnaires for readmission and medical reattendance, including calls to physician. | Up to post-op day 30 |
| Number of Participants With Non-artefactual Percentage of Oxygen Saturation (SpO2)<90% (>30 Seconds) | Number of participants with non-artefactual percentage of oxygen saturation (SpO2) less than 90% for greater than 30 seconds). Collected in the recovery room and chart review | up to post-op day 30 |
| Number of Patients Receiving Rescue Opioids | How many subjects received rescue opioids after surgery | up to post-op day 30 |
| Family Satisfaction With Patient Recovery Based on Five-point Likert Score | Follow-up questionnaire to family on post-op days 1, 5, and 30. Parents will be asked to rank how satisfied they are with their child's recovery by using these two prompts: "I am satisfied with my child's recovery," and "I am satisfied with my child's pain control at home." They will choose from the following options: "Strongly agree = 1", "Agree = 2", "Undecided = 3", "Disagree = 4", "Strongly Disagree =5." Minimum score is 1, Max is 5. Higher scores indicate worse outcomes. Data assessed at post-op days 1, 5, and 30 were averaged. | assessed at post-op days 1, 5, and 30 |
| Number of Participants That Experienced Any Post-operative Bleeding Throughout the Study | Follow-up questionnaires administered on post-operative day 1, 5, ad 30 and chart review. Question: Has your child had any bright red blood in their mouth? Answer options: Yes/No | up to post-op day 30 |
| Memphis |
| Tennessee |
| 38105 |
| United States |
| 29203521 | Background | Harbaugh CM, Lee JS, Hu HM, McCabe SE, Voepel-Lewis T, Englesbe MJ, Brummett CM, Waljee JF. Persistent Opioid Use Among Pediatric Patients After Surgery. Pediatrics. 2018 Jan;141(1):e20172439. doi: 10.1542/peds.2017-2439. Epub 2017 Dec 4. |
| 30088000 | Background | Harbaugh CM, Nalliah RP, Hu HM, Englesbe MJ, Waljee JF, Brummett CM. Persistent Opioid Use After Wisdom Tooth Extraction. JAMA. 2018 Aug 7;320(5):504-506. doi: 10.1001/jama.2018.9023. |
| 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. |
| 31077491 | Background | Franz AM, Dahl JP, Huang H, Verma ST, Martin LD, Martin LD, Low DK. The development of an opioid sparing anesthesia protocol for pediatric ambulatory tonsillectomy and adenotonsillectomy surgery-A quality improvement project. Paediatr Anaesth. 2019 Jul;29(7):682-689. doi: 10.1111/pan.13662. Epub 2019 Jun 19. |
| 30802933 | Background | Frauenknecht J, Kirkham KR, Jacot-Guillarmod A, Albrecht E. Analgesic impact of intra-operative opioids vs. opioid-free anaesthesia: a systematic review and meta-analysis. Anaesthesia. 2019 May;74(5):651-662. doi: 10.1111/anae.14582. Epub 2019 Feb 25. |
| 30802930 | Background | Elkassabany NM, Mariano ER. Opioid-free anaesthesia - what would Inigo Montoya say? Anaesthesia. 2019 May;74(5):560-563. doi: 10.1111/anae.14611. Epub 2019 Feb 25. No abstract available. |
| 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. |
| 21493257 | Background | Baugh RF, Archer SM, Mitchell RB, Rosenfeld RM, Amin R, Burns JJ, Darrow DH, Giordano T, Litman RS, Li KK, Mannix ME, Schwartz RH, Setzen G, Wald ER, Wall E, Sandberg G, Patel MM; American Academy of Otolaryngology-Head and Neck Surgery Foundation. Clinical practice guideline: tonsillectomy in children. Otolaryngol Head Neck Surg. 2011 Jan;144(1 Suppl):S1-30. doi: 10.1177/0194599810389949. |
| 23842193 | Background | Cote CJ, Posner KL, Domino KB. Death or neurologic injury after tonsillectomy in children with a focus on obstructive sleep apnea: houston, we have a problem! Anesth Analg. 2014 Jun;118(6):1276-83. doi: 10.1213/ANE.0b013e318294fc47. |
| 24025114 | Background | McCabe SE, Schulenberg JE, O'Malley PM, Patrick ME, Kloska DD. Non-medical use of prescription opioids during the transition to adulthood: a multi-cohort national longitudinal study. Addiction. 2014 Jan;109(1):102-10. doi: 10.1111/add.12347. Epub 2013 Oct 22. |
| 23433943 | Background | McCabe SE, West BT, Boyd CJ. Medical use, medical misuse, and nonmedical use of prescription opioids: results from a longitudinal study. Pain. 2013 May;154(5):708-713. doi: 10.1016/j.pain.2013.01.011. Epub 2013 Jan 26. |
| 23298996 | Background | McCabe SE, West BT, Boyd CJ. Leftover prescription opioids and nonmedical use among high school seniors: a multi-cohort national study. J Adolesc Health. 2013 Apr;52(4):480-5. doi: 10.1016/j.jadohealth.2012.08.007. Epub 2012 Nov 22. |
| 22822298 | Background | Winters KC, Arria A. Adolescent Brain Development and Drugs. Prev Res. 2011;18(2):21-24. |
| 28203739 | Background | Mason KP. Paediatric emergence delirium: a comprehensive review and interpretation of the literature. Br J Anaesth. 2017 Mar 1;118(3):335-343. doi: 10.1093/bja/aew477. |
| 15195324 | Background | Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004 Jun 30;23(12):1921-86. doi: 10.1002/sim.1783. |
| 28270184 | Background | Althunian TA, de Boer A, Klungel OH, Insani WN, Groenwold RH. Methods of defining the non-inferiority margin in randomized, double-blind controlled trials: a systematic review. Trials. 2017 Mar 7;18(1):107. doi: 10.1186/s13063-017-1859-x. |
| 8569017 | Background | Strom BL, Berlin JA, Kinman JL, Spitz PW, Hennessy S, Feldman H, Kimmel S, Carson JL. Parenteral ketorolac and risk of gastrointestinal and operative site bleeding. A postmarketing surveillance study. JAMA. 1996 Feb 7;275(5):376-82. |
| 11883386 | Background | Forrest JB, Camu F, Greer IA, Kehlet H, Abdalla M, Bonnet F, Ebrahim S, Escolar G, Jage J, Pocock S, Velo G, Langman MJ, Bianchi PG, Samama MM, Heitlinger E; POINT Investigators. Ketorolac, diclofenac, and ketoprofen are equally safe for pain relief after major surgery. Br J Anaesth. 2002 Feb;88(2):227-33. doi: 10.1093/bja/88.2.227. |
| 16620327 | Background | Mowatt G, Cook JA, Fraser C, McKerrow WS, Burr JM. Systematic review of the safety of electrosurgery for tonsillectomy. Clin Otolaryngol. 2006 Apr;31(2):95-102. doi: 10.1111/j.1749-4486.2006.01162.x. |
| 24338331 | Background | Chan DK, Parikh SR. Perioperative ketorolac increases post-tonsillectomy hemorrhage in adults but not children. Laryngoscope. 2014 Aug;124(8):1789-93. doi: 10.1002/lary.24555. Epub 2014 May 27. |
| 31145482 | Background | McClain K, Williams AM, Yaremchuk K. Ketorolac usage in tonsillectomy and uvulopalatopharyngoplasty patients. Laryngoscope. 2020 Apr;130(4):876-879. doi: 10.1002/lary.28077. Epub 2019 May 30. |
| 20705788 | Background | Patel A, Davidson M, Tran MC, Quraishi H, Schoenberg C, Sant M, Lin A, Sun X. Dexmedetomidine infusion for analgesia and prevention of emergence agitation in children with obstructive sleep apnea syndrome undergoing tonsillectomy and adenoidectomy. Anesth Analg. 2010 Oct;111(4):1004-10. doi: 10.1213/ANE.0b013e3181ee82fa. Epub 2010 Aug 12. |
| 20610555 | Background | Olutoye OA, Glover CD, Diefenderfer JW, McGilberry M, Wyatt MM, Larrier DR, Friedman EM, Watcha MF. The effect of intraoperative dexmedetomidine on postoperative analgesia and sedation in pediatric patients undergoing tonsillectomy and adenoidectomy. Anesth Analg. 2010 Aug;111(2):490-5. doi: 10.1213/ANE.0b013e3181e33429. Epub 2010 Jul 7. |
| 15577776 | Background | Lee MS, Montague ML, Hussain SS. Post-tonsillectomy hemorrhage: cold versus hot dissection. Otolaryngol Head Neck Surg. 2004 Dec;131(6):833-6. doi: 10.1016/j.otohns.2004.08.008. |
| 30946442 | Background | Diercks GR, Comins J, Bennett K, Gallagher TQ, Brigger M, Boseley M, Gaudreau P, Rogers D, Setlur J, Keamy D, Cohen MS, Hartnick C. Comparison of Ibuprofen vs Acetaminophen and Severe Bleeding Risk After Pediatric Tonsillectomy: A Noninferiority Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2019 Jun 1;145(6):494-500. doi: 10.1001/jamaoto.2019.0269. |
| 2082311 | Background | Mroszczak EJ, Jung D, Yee J, Bynum L, Sevelius H, Massey I. Ketorolac tromethamine pharmacokinetics and metabolism after intravenous, intramuscular, and oral administration in humans and animals. Pharmacotherapy. 1990;10(6 ( Pt 2)):33S-39S. |
| 15102238 | Background | Macario A, Lipman AG. Ketorolac in the era of cyclo-oxygenase-2 selective nonsteroidal anti-inflammatory drugs: a systematic review of efficacy, side effects, and regulatory issues. Pain Med. 2001 Dec;2(4):336-51. doi: 10.1046/j.1526-4637.2001.01043.x. |
| 30921525 | 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)-Executive Summary. Otolaryngol Head Neck Surg. 2019 Feb;160(2):187-205. doi: 10.1177/0194599818807917. |
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| 26170346 | Background | Mahmoud M, Mason KP. Dexmedetomidine: review, update, and future considerations of paediatric perioperative and periprocedural applications and limitations. Br J Anaesth. 2015 Aug;115(2):171-82. doi: 10.1093/bja/aev226. |
| 29752853 | Background | Tsiotou AG, Malisiova A, Kouptsova E, Mavri M, Anagnostopoulou M, Kalliardou E. Dexmedetomidine for the reduction of emergence delirium in children undergoing tonsillectomy with propofol anesthesia: A double-blind, randomized study. Paediatr Anaesth. 2018 Jul;28(7):632-638. doi: 10.1111/pan.13397. Epub 2018 May 12. |
| Sealed Envelope Ltd. 2012. Power calculator for continuous outcome non-inferiority trial. | View source |
| Buck, ML. Use of Intravenous Ketorolac for Postoperative Analgesia in Infants: Pediatric Pharmacotherapy, A Monthly Newsletter. . 2011 | View source |
| BG001 | Opioid-Free Group (OFG) | Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac. Ketorolac: Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis. Dexmedetomidine: Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Opioid-Free Group (OFG) | Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac. Ketorolac: Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis. Dexmedetomidine: Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure. |
|
|
| Secondary | Number of Participants With Nausea, Vomiting, Pruritis | Collected in recovery room and asked in questionnaires, collected from parents on post-operative days 1, 5, and 30. | Posted | Number | participants | up to post-op day 30 |
|
|
|
| Secondary | Number of Participants Who Sought Unplanned Medical Attention | Number of participants who were readmitted to the hospital and sought unplanned medical attention (phone calls, office visits, emergency department visits) by chart review and questionnaires for readmission and medical reattendance, including calls to physician | Posted | Count of Participants | Participants | up to post-op day 30 |
|
|
|
| Secondary | Number of Participants Who Were Readmitted to the the Hospital | Number of participants who were readmitted to the hospital by chart review and questionnaires for readmission and medical reattendance, including calls to physician. | Posted | Count of Participants | Participants | Up to post-op day 30 |
|
|
|
| Secondary | Number of Participants With Non-artefactual Percentage of Oxygen Saturation (SpO2)<90% (>30 Seconds) | Number of participants with non-artefactual percentage of oxygen saturation (SpO2) less than 90% for greater than 30 seconds). Collected in the recovery room and chart review | Posted | Count of Participants | Participants | up to post-op day 30 |
|
|
|
| Secondary | Number of Patients Receiving Rescue Opioids | How many subjects received rescue opioids after surgery | Posted | Count of Participants | Participants | up to post-op day 30 |
|
|
|
| Secondary | Family Satisfaction With Patient Recovery Based on Five-point Likert Score | Follow-up questionnaire to family on post-op days 1, 5, and 30. Parents will be asked to rank how satisfied they are with their child's recovery by using these two prompts: "I am satisfied with my child's recovery," and "I am satisfied with my child's pain control at home." They will choose from the following options: "Strongly agree = 1", "Agree = 2", "Undecided = 3", "Disagree = 4", "Strongly Disagree =5." Minimum score is 1, Max is 5. Higher scores indicate worse outcomes. Data assessed at post-op days 1, 5, and 30 were averaged. | Posted | Mean | Full Range | score on a scale | assessed at post-op days 1, 5, and 30 |
|
|
|
| Secondary | Number of Participants That Experienced Any Post-operative Bleeding Throughout the Study | Follow-up questionnaires administered on post-operative day 1, 5, ad 30 and chart review. Question: Has your child had any bright red blood in their mouth? Answer options: Yes/No | Posted | Count of Participants | Participants | up to post-op day 30 |
|
|
|
| 0 |
| 18 |
| 2 |
| 18 |
| 4 |
| 18 |
| EG001 | Opioid-Free Group (OFG) | Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac. Ketorolac: Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis. Dexmedetomidine: Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure. | 0 | 17 | 0 | 17 | 6 | 17 |
| Readmission | General disorders | Non-systematic Assessment |
|
| Bleeding Events | Surgical and medical procedures | Non-systematic Assessment |
|
| Dehydration | General disorders | Non-systematic Assessment |
|
| Nausea/Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Emergency department encounter | Surgical and medical procedures | Non-systematic Assessment |
|
Not provided
Not provided
| D009057 |
| Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010880 | Piperidines |
| pruritis |
|