Study Summary
This trial will compare two types of anesthesia for tonsillectomy surgery, one with opioids and one without, to see if the opioid-free option is just as good.
Eligible Conditions
- Tonsillitis
- Opioid Use Disorder
- Surgery
- Sleep Disorders
- Anesthesia
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: up to 2 years
up to 2 years
Bleeding prevalence
Frequency of non-artifactual percentage of oxygen saturation (SpO2)<90% (>30 seconds)
Frequency of readmission and of seeking unplanned medical attention (phone calls, office visits, ED visits)
Percentage of patients receiving rescue opioids
up to 30 minutes
Median Maximum Pain Score
Day 30
Family satisfaction with patient recovery based on seven-point Likert score
Frequency of nausea, vomiting, pruritis
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Traditional Care Group (TCG)
1 of 2
Opioid-Free Group (OFG)
1 of 2
Active Control
Experimental Treatment
550 Total Participants · 2 Treatment Groups
Primary Treatment: Ketorolac · No Placebo Group · Phase 4
Opioid-Free Group (OFG)Experimental Group · 2 Interventions: Ketorolac, Dexmedetomidine · Intervention Types: Drug, Drug
Traditional Care Group (TCG)ActiveComparator Group · 2 Interventions: Morphine, Fentanyl · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketorolac
FDA approved
Dexmedetomidine
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Who is running the clinical trial?
University of Tennessee Health Science CenterOTHER
48 Previous Clinical Trials
24,599 Total Patients Enrolled
University of TennesseeOTHER
185 Previous Clinical Trials
141,449 Total Patients Enrolled
Children's Hospital of PhiladelphiaLead Sponsor
661 Previous Clinical Trials
7,854,936 Total Patients Enrolled
University of PennsylvaniaOTHER
1,873 Previous Clinical Trials
41,146,250 Total Patients Enrolled
Tori Sutherland, MD,MPHPrincipal InvestigatorChildren's Hospital of Philadelphia
Anthony Sheyn, MD, FACSPrincipal InvestigatorUniversity of Tennessee
Eligibility Criteria
Age 2 - 18 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
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- Frauenknecht, J., K. R. Kirkham, A. Jacot‐Guillarmod, and E. Albrecht. 2019. “Analgesic Impact of Intra‐operative Opioids Vs. Opioid‐free Anaesthesia: A Systematic Review and Meta‐analysis”. Anaesthesia. Wiley. doi:10.1111/anae.14582.
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- Elkassabany, N. M., and E. R. Mariano. 2019. “Opioid‐free Anaesthesia – What Would Inigo Montoya Say?”. Anaesthesia. Wiley. doi:10.1111/anae.14611.
- Mitchell, Ron B., Sanford M. Archer, Stacey L. Ishman, Richard M. Rosenfeld, Sarah Coles, Sandra A. Finestone, Norman R. Friedman, et al.. 2019. “Clinical Practice Guideline: Tonsillectomy in Children (update)”. Otolaryngology–head and Neck Surgery. SAGE Publications. doi:10.1177/0194599818801757.
- Baugh, Reginald F., Sanford M. Archer, Ron B. Mitchell, Richard M. Rosenfeld, Raouf Amin, James J. Burns, David H. Darrow, et al.. 2011. “Clinical Practice Guideline: Tonsillectomy in Children”. Otolaryngology–head and Neck Surgery. SAGE Publications. doi:10.1177/0194599810389949.
- Chan, Dylan K., and Sanjay R. Parikh. 2014. “Perioperative Ketorolac Increases Post-tonsillectomy Hemorrhage in Adults but Not Children”. The Laryngoscope. Wiley. doi:10.1002/lary.24555.
- Lee, Michael S. W., Mary-Louise Montague, and S. S. Musheer Hussain Consultant. 2004. “Post-tonsillectomy Hemorrhage: Cold Versus Hot Dissection”. Otolaryngology–head and Neck Surgery. SAGE Publications. doi:10.1016/j.otohns.2004.08.008.
- Diercks, Gillian R., Jill Comins, Kara Bennett, Thomas Q. Gallagher, Matthew Brigger, Mark Boseley, Philip Gaudreau, et al.. 2019. “Comparison of Ibuprofen Vs Acetaminophen and Severe Bleeding Risk After Pediatric Tonsillectomy”. JAMA Otolaryngology–head & Neck Surgery. American Medical Association (AMA). doi:10.1001/jamaoto.2019.0269.
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- Macario, Alex, and Arthur G. Lipman. 2001. “Ketorolac in the Era of Cyclo-oxygenase-2 Selective Nonsteroidal Anti-inflammatory Drugs: A Systematic Review of Efficacy, Side Effects, and Regulatory Issues”. Pain Medicine. Oxford University Press (OUP). doi:10.1046/j.1526-4637.2001.01043.x.
- Mitchell, Ron B., Sanford M. Archer, Stacey L. Ishman, Richard M. Rosenfeld, Sarah Coles, Sandra A. Finestone, Norman R. Friedman, et al.. 2019. “Clinical Practice Guideline: Tonsillectomy in Children (update)—executive Summary”. Otolaryngology–head and Neck Surgery. SAGE Publications. doi:10.1177/0194599818807917.
- Volkow, Nora D., Emily B. Jones, Emily B. Einstein, and Eric M. Wargo. 2019. “Prevention and Treatment of Opioid Misuse and Addiction”. JAMA Psychiatry. American Medical Association (AMA). doi:10.1001/jamapsychiatry.2018.3126.
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- Harbaugh, Calista M., Jay S. Lee, Hsou Mei Hu, Sean Esteban McCabe, Terri Voepel-Lewis, Michael J. Englesbe, Chad M. Brummett, and Jennifer F. Waljee. 2018. “Persistent Opioid Use Among Pediatric Patients After Surgery”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2017-2439.
- Franz, Amber M., John P. Dahl, Henry Huang, Shilpa T. Verma, Lynn D. Martin, Lizabeth D. Martin, and Daniel King‐Wai Low. 2019. “The Development of an Opioid Sparing Anesthesia Protocol for Pediatric Ambulatory Tonsillectomy and Adenotonsillectomy Surgery—a Quality Improvement Project”. Edited by Suellen Walker. Pediatric Anesthesia. Wiley. doi:10.1111/pan.13662.
- Coté, Charles J., Karen L. Posner, and Karen B. Domino. 2014. “Death or Neurologic Injury After Tonsillectomy in Children with a Focus on Obstructive Sleep Apnea”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/ane.0b013e318294fc47.
- McCabe, Sean Esteban, Brady T. West, and Carol J. Boyd. 2013. “Leftover Prescription Opioids and Nonmedical Use Among High School Seniors: A Multi-cohort National Study”. Journal of Adolescent Health. Elsevier BV. doi:10.1016/j.jadohealth.2012.08.007.
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- Mudd, Pamela A., Princy Thottathil, Terri Giordano, Ralph F. Wetmore, Lisa Elden, Abbas F. Jawad, Luis Ahumada, and Jorge A. Gálvez. 2017. “Association Between Ibuprofen Use and Severity of Surgically Managed Posttonsillectomy Hemorrhage”. JAMA Otolaryngology–head & Neck Surgery. American Medical Association (AMA). doi:10.1001/jamaoto.2016.3839.
- Gupta, Punkaj, Wendy Whiteside, Arash Sabati, Tiffany M. Tesoro, Jeffrey M. Gossett, Joseph D. Tobias, and Stephen J. Roth. 2012. “Safety and Efficacy of Prolonged Dexmedetomidine Use in Critically Ill Children with Heart Disease*”. Pediatric Critical Care Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/pcc.0b013e318253c7f1.
- Frauenknecht, J., K. R. Kirkham, A. Jacot‐Guillarmod, and E. Albrecht. 2019. “Analgesic Impact of Intra‐operative Opioids Vs. Opioid‐free Anaesthesia: A Systematic Review and Meta‐analysis”. Anaesthesia. Wiley. doi:10.1111/anae.14582.
- Mitchell, Ron B., Sanford M. Archer, Stacey L. Ishman, Richard M. Rosenfeld, Sarah Coles, Sandra A. Finestone, Norman R. Friedman, et al.. 2019. “Clinical Practice Guideline: Tonsillectomy in Children (update)”. Otolaryngology–head and Neck Surgery. SAGE Publications. doi:10.1177/0194599818801757.
- Olutoye, Olutoyin A., Chris D. Glover, John W. Diefenderfer, Michael McGilberry, Matthew M. Wyatt, Deidre R. Larrier, Ellen M. Friedman, and Mehernoor F. Watcha. 2010. “The Effect of Intraoperative Dexmedetomidine on Postoperative Analgesia and Sedation in Pediatric Patients Undergoing Tonsillectomy and Adenoidectomy”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/ane.0b013e3181e33429.
- Diercks, Gillian R., Jill Comins, Kara Bennett, Thomas Q. Gallagher, Matthew Brigger, Mark Boseley, Philip Gaudreau, et al.. 2019. “Comparison of Ibuprofen Vs Acetaminophen and Severe Bleeding Risk After Pediatric Tonsillectomy”. JAMA Otolaryngology–head & Neck Surgery. American Medical Association (AMA). doi:10.1001/jamaoto.2019.0269.
- Mahmoud, M., and K.P. Mason. 2015. “Dexmedetomidine: Review, Update, and Future Considerations of Paediatric Perioperative and Periprocedural Applications and Limitations”. British Journal of Anaesthesia. Elsevier BV. doi:10.1093/bja/aev226.
- Scholl, Lawrence, Puja Seth, Mbabazi Kariisa, Nana Wilson, and Grant Baldwin. 2018. “Drug and Opioid-involved Overdose Deaths — United States, 2013–2017”. MMWR. Morbidity and Mortality Weekly Report. Centers for Disease Control MMWR Office. doi:10.15585/mmwr.mm675152e1.
- Harbaugh, Calista M., Jay S. Lee, Hsou Mei Hu, Sean Esteban McCabe, Terri Voepel-Lewis, Michael J. Englesbe, Chad M. Brummett, and Jennifer F. Waljee. 2018. “Persistent Opioid Use Among Pediatric Patients After Surgery”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2017-2439.
- Kelly, Lauren E., Doron D. Sommer, Jayant Ramakrishna, Stephanie Hoffbauer, Sadaf Arbab-tafti, Diane Reid, Jonathan Maclean, and Gideon Koren. 2015. “Morphine or Ibuprofen for Post-tonsillectomy Analgesia: A Randomized Trial”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2014-1906.
- McCabe, Sean Esteban, Brady T. West, and Carol J. Boyd. 2013. “Leftover Prescription Opioids and Nonmedical Use Among High School Seniors: A Multi-cohort National Study”. Journal of Adolescent Health. Elsevier BV. doi:10.1016/j.jadohealth.2012.08.007.
- Mason, K.P.. 2017. “Paediatric Emergence Delirium: A Comprehensive Review and Interpretation of the Literature”. British Journal of Anaesthesia. Elsevier BV. doi:10.1093/bja/aew477.
- Baugh, Reginald F., Sanford M. Archer, Ron B. Mitchell, Richard M. Rosenfeld, Raouf Amin, James J. Burns, David H. Darrow, et al.. 2011. “Clinical Practice Guideline: Tonsillectomy in Children”. Otolaryngology–head and Neck Surgery. SAGE Publications. doi:10.1177/0194599810389949.
- Patel, Anuradha, Melissa Davidson, Minh C. J. Tran, Huma Quraishi, Catherine Schoenberg, Manasee Sant, Albert Lin, and Xiuru Sun. 2010. “Dexmedetomidine Infusion for Analgesia and Prevention of Emergence Agitation in Children with Obstructive Sleep Apnea Syndrome Undergoing Tonsillectomy and Adenoidectomy”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/ane.0b013e3181ee82fa.
- Gupta, Punkaj, Wendy Whiteside, Arash Sabati, Tiffany M. Tesoro, Jeffrey M. Gossett, Joseph D. Tobias, and Stephen J. Roth. 2012. “Safety and Efficacy of Prolonged Dexmedetomidine Use in Critically Ill Children with Heart Disease*”. Pediatric Critical Care Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/pcc.0b013e318253c7f1.
- Tsiotou, Adelais G., Anna Malisiova, Elena Kouptsova, Maria Mavri, Maria Anagnostopoulou, and Evagelia Kalliardou. 2018. “Dexmedetomidine for the Reduction of Emergence Delirium in Children Undergoing Tonsillectomy with Propofol Anesthesia: A Double-blind, Randomized Study”. Pediatric Anesthesia. Wiley. doi:10.1111/pan.13397.
- Mudd PA, Thottathil P, Giordano T, Wetmore RF, Elden L, Jawad AF, Ahumada L, Galvez JA. Association Between Ibuprofen Use and Severity of Surgically Managed Posttonsillectomy Hemorrhage. JAMA Otolaryngol Head Neck Surg. 2017 Jul 1;143(7):712-717. doi: 10.1001/jamaoto.2016.3839.
- 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.
- 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.
- 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.
- 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.
- Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004 Jun 30;23(12):1921-86. doi: 10.1002/sim.1783.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 2020. "Opioid-Free Anesthetic for Tonsillectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04528173.
Frequently Asked Questions
Is enrollment open to minors for this medical experiment?
"This particular medical research is open to minors between 2 and 18 years of age. There are 159 trials specifically for people in this demographic, while 633 studies concentrate on individuals over 65." - Anonymous Online Contributor
Unverified Answer
Are there other examinations that have been conducted concerning Ketorolac?
"Currently, there are 220 ongoing studies on ketorolac and 49 of them have entered Phase 3. With 425 recruiting sites across the United States, many of which in Boston Massachusetts, this medication is being heavily researched." - Anonymous Online Contributor
Unverified Answer
To what degree is Ketorolac a secure medication for individuals?
"The safety of Ketorolac has been clinically validated, thus it earned a score of 3." - Anonymous Online Contributor
Unverified Answer
How many participants is the maximum capacity for this clinical experiment?
"Affirmative, clinicaltrials.gov reveals that the trial is actively seeking participants. Initially posted on July 22nd 2020 and modified as recently as August 29th 2022, this medical research requires 550 individuals to be enrolled from two separate facilities." - Anonymous Online Contributor
Unverified Answer
Is eligibility for this trial open at the present time?
"Correct. Data held on clinicaltrials.gov suggests that recruitment for this trial, which was originally published on July 22nd 2020, is currently ongoing. Approximately 550 people need to be recruited from 2 distinct medical facilities." - Anonymous Online Contributor
Unverified Answer
For what medical conditions is Ketorolac commonly prescribed?
"Ketorolac is generally prescribed to reduce the effects of general anesthesia. In addition, it's also utilized in cases such as miosis disorder and intraocular lens replacement." - Anonymous Online Contributor
Unverified Answer
Could I fulfill the criteria for this experimental research?
"This medical research is seeking 550 pediatric patients between the ages of two and eighteen suffering from tonsillitis. To be eligible, participants must meet these conditions: Male or female with a maximum American Society of Anesthesiologists (ASA) physical classification score 3; post-menarche girls must present a negative pregnancy test result; undergo scheduled tonsillectomy/tonsillectomy in combination with adenoidectomy and/or ear tube placement at the Children's Hospital of Philadelphia (CHOP)'s main or ambulatory surgical centers." - Anonymous Online Contributor
Unverified Answer