Muscle Relaxation for Pediatric Adenotonsillectomy

Summary

The goal of this clinical trial is to compare general anesthesia with muscle relaxation and reversal of the relaxation at the end of surgery or without muscle relaxation in high-risk children having adenotonsillectomy surgery. The main questions it aims to answer are: 1. What is the impact of general anesthesia with muscle relaxation on opioid pain medication requirements during and after adenotonsillectomy? 2. What is the impact of general anesthesia with muscle relaxation on postoperative breathing complications and the adequacy of postoperative lung air volumes during breathing? Participants will wear three additional, noninvasive monitors during surgery, and one additional monitor after surgery. The amount of opioid pain medication required will be tracked, and the patient will be observed postoperatively for breathing complications. Measurements will be collected from the monitor worn postoperatively. Researchers will compare general anesthesia with muscle relaxation and reversal of relaxation at the end of surgery with general anesthesia without muscle relaxation to test the hypothesis that the approach using muscle relaxation reduces the amount of opioid pain medication required during and after surgery.

Timeline

Start

2024-04-10

Primary completion

2024-09-27

Completion

2024-09-27

Publications

• Background Johnson RF, Zhang J, Chorney SR, Kou YF, Lenes-Voit F, Ulualp S, Liu C, Mitchell RB. Estimations of Inpatient and Ambulatory Pediatric Tonsillectomy in the United States: A Cross-sectional Analysis. Otolaryngol Head Neck Surg. 2023 Aug;169(2):258-266. doi: 10.1002/ohn.268. Epub 2023 Feb 5.
• Background Rossi NA, Spaude J, Ohlstein JF, Pine HS, Daram S, McKinnon BJ, Szeremeta W. Apnea-hypopnea index severity as an independent predictor of post-tonsillectomy respiratory complications in pediatric patients: A retrospective study. Ear Nose Throat J. 2024 Jul;103(7):424-429. doi: 10.1177/01455613211059468. Epub 2021 Dec 1.
• Background Smith DF, Spiceland CP, Ishman SL, Engorn BM, Donohue C, Park PS, Benke JR, Frazee T, Brown RH, Dalesio NM. Admission Criteria for Children With Obstructive Sleep Apnea After Adenotonsillectomy: Considerations for Cost. J Clin Sleep Med. 2017 Dec 15;13(12):1463-1472. doi: 10.5664/jcsm.6850.
• Background Allareddy V, Martinez-Schlurmann N, Rampa S, Nalliah RP, Lidsky KB, Allareddy V, Rotta AT. Predictors of Complications of Tonsillectomy With or Without Adenoidectomy in Hospitalized Children and Adolescents in the United States, 2001-2010: A Population-Based Study. Clin Pediatr (Phila). 2016 Jun;55(7):593-602. doi: 10.1177/0009922815616885. Epub 2015 Nov 24.
• 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.
• Background Voss T, Wang A, DeAngelis M, Speek M, Saldien V, Hammer GB, Wrishko R, Herring WJ. Sugammadex for reversal of neuromuscular blockade in pediatric patients: Results from a phase IV randomized study. Paediatr Anaesth. 2022 Mar;32(3):436-445. doi: 10.1111/pan.14370. Epub 2021 Dec 17.
• Background Kou YF, Sakai M, Shah GB, Mitchell RB, Johnson RF. Postoperative respiratory complications and racial disparities following inpatient pediatric tonsillectomy: A cross-sectional study. Laryngoscope. 2019 Apr;129(4):995-1000. doi: 10.1002/lary.27405. Epub 2018 Nov 9.
• 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.
• Background Goldman JL, Baugh RF, Davies L, Skinner ML, Stachler RJ, Brereton J, Eisenberg LD, Roberson DW, Brenner MJ. Mortality and major morbidity after tonsillectomy: etiologic factors and strategies for prevention. Laryngoscope. 2013 Oct;123(10):2544-53. doi: 10.1002/lary.23926. Epub 2013 Apr 17.
• Background Baldo BA, Rose MA. Mechanisms of opioid-induced respiratory depression. Arch Toxicol. 2022 Aug;96(8):2247-2260. doi: 10.1007/s00204-022-03300-7. Epub 2022 Apr 26.
• Background Waters KA, McBrien F, Stewart P, Hinder M, Wharton S. Effects of OSA, inhalational anesthesia, and fentanyl on the airway and ventilation of children. J Appl Physiol (1985). 2002 May;92(5):1987-94. doi: 10.1152/japplphysiol.00619.2001.
• Background Dalesio NM, Lee CKK, Hendrix CW, Kerns N, Hsu A, Clarke W, Collaco JM, McGrath-Morrow S, Yaster M, Brown RH, Schwartz AR. Effects of Obstructive Sleep Apnea and Obesity on Morphine Pharmacokinetics in Children. Anesth Analg. 2020 Sep;131(3):876-884. doi: 10.1213/ANE.0000000000004509.
• Background Gozal D, Burnside MM. Increased upper airway collapsibility in children with obstructive sleep apnea during wakefulness. Am J Respir Crit Care Med. 2004 Jan 15;169(2):163-7. doi: 10.1164/rccm.200304-590OC. Epub 2003 Oct 2.
• Background Marcus CL, McColley SA, Carroll JL, Loughlin GM, Smith PL, Schwartz AR. Upper airway collapsibility in children with obstructive sleep apnea syndrome. J Appl Physiol (1985). 1994 Aug;77(2):918-24. doi: 10.1152/jappl.1994.77.2.918.
• Background Brown KA, Laferriere A, Moss IR. Recurrent hypoxemia in young children with obstructive sleep apnea is associated with reduced opioid requirement for analgesia. Anesthesiology. 2004 Apr;100(4):806-10; discussion 5A. doi: 10.1097/00000542-200404000-00009.
• Background von Ungern-Sternberg BS, Sommerfield D, Slevin L, Drake-Brockman TFE, Zhang G, Hall GL. Effect of Albuterol Premedication vs Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies: The REACT Randomized Clinical Trial. JAMA Pediatr. 2019 Jun 1;173(6):527-533. doi: 10.1001/jamapediatrics.2019.0788.
• Background Shen F, Zhang Q, Xu Y, Wang X, Xia J, Chen C, Liu H, Zhang Y. Effect of Intranasal Dexmedetomidine or Midazolam for Premedication on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial. JAMA Netw Open. 2022 Aug 1;5(8):e2225473. doi: 10.1001/jamanetworkopen.2022.25473.
• Background Efune PN, Longanecker JM, Alex G, Saynhalath R, Khan U, Rivera K, Jerome AP, Boone W, Szmuk P. Use of dexmedetomidine and opioids as the primary anesthetic in infants and young children: A retrospective cohort study. Paediatr Anaesth. 2020 Sep;30(9):1013-1019. doi: 10.1111/pan.13945. Epub 2020 Jul 26.
• Background Efune PN, Saynhalath R, Blackwell JM, Steiner JW, Olomu PN, Szmuk P. The Truview PCD video laryngoscope for nasotracheal intubation in pediatric patients: A subset analysis from a prospective randomized controlled trial. Paediatr Anaesth. 2020 Oct;30(10):1157-1158. doi: 10.1111/pan.14005. Epub 2020 Sep 6. No abstract available.
• Background Saynhalath R, Alex G, Efune PN, Szmuk P, Zhu H, Sanford EL. Anesthetic Complications Associated With Severe Acute Respiratory Syndrome Coronavirus 2 in Pediatric Patients. Anesth Analg. 2021 Aug 1;133(2):483-490. doi: 10.1213/ANE.0000000000005606.
• Background Hamilton TB, Thung A, Tobias JD, Jatana KR, Raman VT. Adenotonsillectomy and postoperative respiratory adverse events: A retrospective study. Laryngoscope Investig Otolaryngol. 2020 Jan 3;5(1):168-174. doi: 10.1002/lio2.340. eCollection 2020 Feb.
• Background Templeton TW, Goenaga-Diaz EJ, Downard MG, McLouth CJ, Smith TE, Templeton LB, Pecorella SH, Hammon DE, O'Brien JJ, McLaughlin DH, Lawrence AE, Tennant PR, Ririe DG. Assessment of Common Criteria for Awake Extubation in Infants and Young Children. Anesthesiology. 2019 Oct;131(4):801-808. doi: 10.1097/ALN.0000000000002870.
• Background Chisholm AG, Sathyamoorthy M, Seals SR, Carron JD. Does intravenous acetaminophen reduce perioperative opioid use in pediatric tonsillectomy? Am J Otolaryngol. 2019 Nov-Dec;40(6):102294. doi: 10.1016/j.amjoto.2019.102294. Epub 2019 Sep 9.
• Background Lammers CR, Schwinghammer AJ, Hall B, Kriss RS, Aizenberg DA, Funamura JL, Senders CW, Nittur V, Applegate RL 2nd. Comparison of Oral Loading Dose to Intravenous Acetaminophen in Children for Analgesia After Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial. Anesth Analg. 2021 Dec 1;133(6):1568-1576. doi: 10.1213/ANE.0000000000005678.
• Efune PN, Nakonezny PA, Pinales P, Okanlawon P, Klatt CW, Meghani K, Zhang LJ, Foster SN, Poppino KF, Cerza SP, Szmuk P, Saynhalath R. Effect of neuromuscular blockade on opioid consumption in high-risk children undergoing adenotonsillectomy: A randomized-controlled trial. J Clin Anesth. 2026 Jun;112:112232. doi: 10.1016/j.jclinane.2026.112232. Epub 2026 May 9.

Drugs

Indications

No indication recorded.