Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery

A Randomized Controlled Trial to Compare Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery

A RCT to compare hydromorphone versus fentanyl for pain control following tonsillectomy or adenotonsillectomy surgery.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Tonsillitis
• Intervention / Treatment: Drug: Fentanyl; Drug: Hydromorphone

Detailed Description

This is a randomized clinical trial with masked assessment, comparing recovery indices for patients receiving intermediate acting versus short acting opioid analgesia using hydromorphone or fentanyl as intraoperative analgesics. An otherwise standardized anesthetic and analgesic regimen will be utilized, consistent with routine care at SLCH. Patients will be randomized 1:1 in block sizes of 5 per group. Patients will be randomized to receive either hydromorphone or fentanyl throughout the perioperative period by opening a sealed protocol envelope.

• Study Type: Interventional
• Enrollment (Actual): 189
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine/Barnes-Jewish Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Children ages 2 to 15 years old
2. Presenting for tonsillectomy or adenotonsillectomy surgery
3. American Society of Anesthesiologists Physical Status (ASAPS) Classification 1, 2 or 3
4. Provide Informed Consent / Assent (as appropriate)

Exclusion Criteria:

1. Additional Concurrent surgeries, exclusive of myringotomy tubes, minor oral/nasal procedures (e.g. frenulectomy), and endoscopic procedures
2. Revision tonsillectomy or revision adenotonsillectomy surgery
3. Known pregnancy
4. Any condition which would make the participant, in the opinion of the investigator or the attending anesthesiologist caring for the patient, unsuitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hydromorphone	Drug: Hydromorphone; Patients will be randomized to one of two opioids for the treatment of post-operative pain.
Active Comparator: Fentanyl	Drug: Fentanyl; Fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Requiring Rescue Intravenous Opioid	Number	up to 6 hours post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Participant's Pain	Revised Face, Legs, Activity, Cry, Consolability (rFLACC) Scale Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. 0=no pain/relaxed, 10=distressed/in pain	Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU.
Evaluation of Participant's SpO2 Saturation	SpO2 %	Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU.
Respiratory and PONV Events in PACU		up to 6 hours following surgery
Respiratory and PONV Events at Home	Survey sent to parent by email postoperatively	up to 7 days following surgery

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Michael Montana, MD PhD, Washington University School of Medicine

Publications and helpful links

General Publications

• Bhattacharyya N, Lin HW. Changes and consistencies in the epidemiology of pediatric adenotonsillar surgery, 1996-2006. Otolaryngol Head Neck Surg. 2010 Nov;143(5):680-4. doi: 10.1016/j.otohns.2010.06.918.
• Friedman NR, Perkins JN, McNair B, Mitchell RB. Current practice patterns for sleep-disordered breathing in children. Laryngoscope. 2013 Apr;123(4):1055-8. doi: 10.1002/lary.23709. Epub 2013 Feb 4.
• Brown KA. Outcome, risk, and error and the child with obstructive sleep apnea. Paediatr Anaesth. 2011 Jul;21(7):771-80. doi: 10.1111/j.1460-9592.2011.03597.x. Epub 2011 May 3.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2020
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: December 27, 2019
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Nervous System Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Otorhinolaryngologic Diseases; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Pharyngeal Diseases; Sleep Apnea Syndromes; Pharyngitis; Sleep Apnea, Obstructive; Tonsillitis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Fentanyl; Hydromorphone
• Other Study ID Numbers: 201912042; UL1TR002345 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes