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Opioid-Free Anesthetic for Tonsillectomy

NCT04528173 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-12-20

Study results available
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Summary

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

Conditions

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Tori Sutherland, MD,MPH · Children's Hospital of Philadelphia

  • Anthony Sheyn, MD, FACS · University of Tennessee

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-22
Primary Completion
2023-08-22
Completion
2023-08-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04528173 on ClinicalTrials.gov