NCT04230681

Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 2 Years – 15 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Obstructive Sleep Apnea
• Tonsillitis

Interventions

Type	Name	Description
DRUG	Hydromorphone	Patients will be randomized to one of two opioids for the treatment of post-operative pain.
DRUG	Fentanyl	Fentanyl

Timeline

• Start date: 2020-02-26
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2020-01-18
• Last updated: 2024-12-18
• Results posted: 2024-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study