Trial Outcomes & Findings for Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery (NCT NCT04230681)

NCT ID: NCT04230681

Last Updated: 2024-12-18

Results Overview

Number

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 189 participants
• Primary outcome timeframe: up to 6 hours post surgery
• Results posted on: 2024-12-18

Participant Flow

Participant milestones

Measure	Hydromorphone Pediatric patients will be randomized to one of two arms. Arm 1 will receive intravenous hydromorphone intraoperatively following induction of general anesthesia. Arm 2 will receive intravenous fentanyl in the operating room following induction of general anesthesia.	Fentanyl Pediatric patients will be randomized to one of two arms. Arm 1 will receive intravenous hydromorphone intraoperatively following induction of general anesthesia. Arm 2 will receive intravenous fentanyl in the operating room following induction of general anesthesia.
Overall Study STARTED	93	95
Overall Study COMPLETED	90	90
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Measure	Hydromorphone Pediatric patients will be randomized to one of two arms. Arm 1 will receive intravenous hydromorphone intraoperatively following induction of general anesthesia. Arm 2 will receive intravenous fentanyl in the operating room following induction of general anesthesia.	Fentanyl Pediatric patients will be randomized to one of two arms. Arm 1 will receive intravenous hydromorphone intraoperatively following induction of general anesthesia. Arm 2 will receive intravenous fentanyl in the operating room following induction of general anesthesia.
Overall Study Physician Decision	2	3
Overall Study Investigational Pharmacy unable to provide medications in timely manner	1	1
Overall Study IV inadvertently removed	0	1

Baseline Characteristics

Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery

Baseline characteristics by cohort

Measure	Hydromorphone n=90 Participants Pediatric patients randomized to receive hydromorphone intravenously in the operating room.	Fentanyl n=90 Participants Pediatric patients randomized to receive fentanyl intravenously in the operating room.	Total n=180 Participants Total of all reporting groups
Age, Categorical <=18 years	90 Participants n=5 Participants	90 Participants n=7 Participants	180 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	40 Participants n=7 Participants	76 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	50 Participants n=7 Participants	104 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	86 Participants n=5 Participants	87 Participants n=7 Participants	173 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) White	68 Participants n=5 Participants	67 Participants n=7 Participants	135 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 6 hours post surgery

Number

Outcome measures

Measure	Hydromorphone n=90 Participants Pediatric patients randomized to hydromorphone intravenously in the operating room.	Fentanyl n=90 Participants Pediatric patients randomized to fentanyl intravenously in the operating room.
Number of Patients Requiring Rescue Intravenous Opioid	48 Participants	66 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Hydromorphone n=90 Participants Pediatric patients randomized to hydromorphone intravenously in the operating room.	Fentanyl n=90 Participants Pediatric patients randomized to fentanyl intravenously in the operating room.
Evaluation of Participant's Pain 30min	1.7 score on a scale Standard Deviation 2.6	2.7 score on a scale Standard Deviation 2.9
Evaluation of Participant's Pain 45min	0.7 score on a scale Standard Deviation 1.4	2.4 score on a scale Standard Deviation 2.4
Evaluation of Participant's Pain 60min	0.5 score on a scale Standard Deviation 1.1	2.1 score on a scale Standard Deviation 2.0
Evaluation of Participant's Pain 10min	2.3 score on a scale Standard Deviation 3.1	3.5 score on a scale Standard Deviation 3.6
Evaluation of Participant's Pain 15min	2.3 score on a scale Standard Deviation 2.5	3.4 score on a scale Standard Deviation 3.3
Evaluation of Participant's Pain 0min	2.8 score on a scale Standard Deviation 3.5	4.3 score on a scale Standard Deviation 3.9
Evaluation of Participant's Pain 5min	2.7 score on a scale Standard Deviation 3.5	3.7 score on a scale Standard Deviation 3.9

SECONDARY outcome

Timeframe: Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU.

SpO2 %

Outcome measures

Measure	Hydromorphone n=90 Participants Pediatric patients randomized to hydromorphone intravenously in the operating room.	Fentanyl n=90 Participants Pediatric patients randomized to fentanyl intravenously in the operating room.
Evaluation of Participant's SpO2 Saturation 0min	96.9 percentage of SpO2 saturation Standard Deviation 2.7	96.6 percentage of SpO2 saturation Standard Deviation 2.7
Evaluation of Participant's SpO2 Saturation 45min	96.8 percentage of SpO2 saturation Standard Deviation 2.2	97.6 percentage of SpO2 saturation Standard Deviation 1.7
Evaluation of Participant's SpO2 Saturation 60min	96.7 percentage of SpO2 saturation Standard Deviation 2.3	97.4 percentage of SpO2 saturation Standard Deviation 2.0
Evaluation of Participant's SpO2 Saturation 5min	97.3 percentage of SpO2 saturation Standard Deviation 2.8	96.1 percentage of SpO2 saturation Standard Deviation 9.6
Evaluation of Participant's SpO2 Saturation 10min	97.4 percentage of SpO2 saturation Standard Deviation 2.2	97.3 percentage of SpO2 saturation Standard Deviation 2.5
Evaluation of Participant's SpO2 Saturation 15min	97.1 percentage of SpO2 saturation Standard Deviation 2.7	97.7 percentage of SpO2 saturation Standard Deviation 2.1
Evaluation of Participant's SpO2 Saturation 30min	96.9 percentage of SpO2 saturation Standard Deviation 2.1	96.8 percentage of SpO2 saturation Standard Deviation 9.0

SECONDARY outcome

Timeframe: up to 6 hours following surgery

Outcome measures

Measure	Hydromorphone n=90 Participants Pediatric patients randomized to hydromorphone intravenously in the operating room.	Fentanyl n=90 Participants Pediatric patients randomized to fentanyl intravenously in the operating room.
Respiratory and PONV Events in PACU Witnessed apnea in PACU	3 Participants	4 Participants
Respiratory and PONV Events in PACU Witnessed desaturation below 90% in PACU	9 Participants	11 Participants
Respiratory and PONV Events in PACU PONV in PACU	1 Participants	2 Participants
Respiratory and PONV Events in PACU No events	77 Participants	73 Participants

SECONDARY outcome

Timeframe: up to 7 days following surgery

Survey sent to parent by email postoperatively

Outcome measures

Measure	Hydromorphone n=64 Participants Pediatric patients randomized to hydromorphone intravenously in the operating room.	Fentanyl n=59 Participants Pediatric patients randomized to fentanyl intravenously in the operating room.
Respiratory and PONV Events at Home Vomiting since discharge	7 Participants	9 Participants
Respiratory and PONV Events at Home Nausea since discharge	10 Participants	13 Participants
Respiratory and PONV Events at Home Problems breathing since discharge	1 Participants	2 Participants
Respiratory and PONV Events at Home No events	46 Participants	35 Participants

Adverse Events

Hydromorphone

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Fentanyl

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Hydromorphone n=90 participants at risk Pediatric patients will be randomized to receive one of either hydromorphone or fentanyl intravenously in the operating room.	Fentanyl n=90 participants at risk Pediatric patients will be randomized to receive one of either hydromorphone or fentanyl intravenously in the operating room.
Renal and urinary disorders Readmitted for urinary retention	1.1% 1/90 • 2 weeks	0.00% 0/90 • 2 weeks
Blood and lymphatic system disorders Postoperative tonsillar bleed	2.2% 2/90 • 2 weeks	3.3% 3/90 • 2 weeks
Infections and infestations Fever	1.1% 1/90 • 2 weeks	1.1% 1/90 • 2 weeks
Gastrointestinal disorders Prolonged admission for poor oral intake	8.9% 8/90 • 2 weeks	3.3% 3/90 • 2 weeks
Skin and subcutaneous tissue disorders Tongue Injury	0.00% 0/90 • 2 weeks	1.1% 1/90 • 2 weeks
Gastrointestinal disorders Readmitted for nausea or vomiting	1.1% 1/90 • 2 weeks	2.2% 2/90 • 2 weeks
Gastrointestinal disorders Prolonged admission for nausea or vomiting	1.1% 1/90 • 2 weeks	2.2% 2/90 • 2 weeks
Vascular disorders Postoperative Hypotension	1.1% 1/90 • 2 weeks	0.00% 0/90 • 2 weeks

Additional Information

Dr. Greg Miller

Washington University

Phone: 314-454-6000

Email: g.c.miller@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place