Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery

Early Phase 1CompletedNCT04230681

Washington University School of Medicine189 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

189

Conditions

Obstructive Sleep Apnea Tonsillitis

Interventions

HydromorphoneDRUG

Patients will be randomized to one of two opioids for the treatment of post-operative pain.

FentanylDRUG

Fentanyl

Eligibility

Sex: ALLMin age: 2 YearsMax age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Number of Patients Requiring Rescue Intravenous Opioid

Number

Time frame: up to 6 hours post surgery

Secondary Outcomes

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

Time frame: 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 %

Time frame: 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

Time frame: up to 6 hours following surgery

Respiratory and PONV Events at Home

Survey sent to parent by email postoperatively

Time frame: up to 7 days following surgery

Data from ClinicalTrials.gov

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