Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery

Early Phase 1

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Additional Concurrent surgeries, exclusive of myringotomy tubes, minor oral/nasal procedures (e.g. frenulectomy), and endoscopic procedures
Revision tonsillectomy or revision adenotonsillectomy surgery
Known pregnancy
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.

Arm && Interventions

Group	Intervention	Description
Fentanyl	Fentanyl	-
Hydromorphone	Hydromorphone	-

Primary Outcome Measures

Name	Time	Method
Number of Patients Requiring Rescue Intravenous Opioid	up to 6 hours post surgery	Number

Secondary Outcome Measures

Name	Time	Method
Evaluation of Participant's Pain	Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU.	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
Evaluation of Participant's SpO2 Saturation	Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU.	SpO2 %
Respiratory and PONV Events at Home	up to 7 days following surgery	Survey sent to parent by email postoperatively
Respiratory and PONV Events in PACU	up to 6 hours following surgery

Locations (1): Washington University School of Medicine/Barnes-Jewish Hospital
🇺🇸
Saint Louis, Missouri, United States
Washington University School of Medicine/Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States