NCT04528173

Opioid-Free Anesthetic for Tonsillectomy

Opioid-Free Versus Transitional Anesthetic With Opioids From Tonsillectomy

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Accepted

Summary

Prospective randomized controlled trial to determine if opioid-free anesthetic for tonsillectomy is non-inferior to standard opioid-containing anesthetic

Detailed description

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.

Conditions

• Anesthesia
• Opioid Use
• Tonsillitis
• Sleep Disorder
• Surgery

Interventions

Type	Name	Description
DRUG	Ketorolac	Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis.
DRUG	Dexmedetomidine	Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.
DRUG	Morphine	Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care.
DRUG	Fentanyl	Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.

Timeline

• Start date: 2020-07-22
• Primary completion: 2023-08-22
• Completion: 2023-08-22
• First posted: 2020-08-27
• Last updated: 2024-12-20
• Results posted: 2024-12-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study