Hydromorphone for Tonsillitis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tonsillitis+1 MoreFentanyl - Drug
Eligibility
2 - 15
All Sexes
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Study Summary

This trial compared the effects of two different pain medications on post-surgery pain relief.

Eligible Conditions
  • Tonsillitis
  • Obstructive Sleep Apnea

Treatment Effectiveness

Study Objectives

4 Primary · 14 Secondary · Reporting Duration: up to 48 hours post surgery

Hour 12
ASA physical status classification score from preoperative assessment - fentanyl group
ASA physical status classification score from preoperative assessment - hydromorphone group
Preoperative Amsterdam Preoperative Anxiety Scale - fentanyl group
Preoperative Amsterdam Preoperative Anxiety Scale - hydromorphone group
Yale Preoperative Anxiety Scale - fentanyl group
Yale Preoperative Anxiety Scale - hydromorphone group
Hour 48
Adverse events - fentanyl group
Adverse events - hydromorphone group
Child Hospital Survey (CAHPS) - fentanyl group
Child Hospital Survey (CAHPS) - hydromorphone group
NIH PROMIS - fentanyl group
NIH PROMIS - hydromorphone group
Optional opioid plasma concentrations - fentanyl group
Optional opioid plasma concentrations - hydromorphone group
Hour 48
Amount of rescue opioid medications administered - fentanyl group
Amount of rescue opioid medications administered - hydromorphone group
Evaluation of participant's pain - fentanyl group
Evaluation of participant's pain - hydromorphone group

Trial Safety

Trial Design

2 Treatment Groups

Hydromorphone
1 of 2
Fentanyl
1 of 2

Active Control

300 Total Participants · 2 Treatment Groups

Primary Treatment: Hydromorphone · No Placebo Group · Phase < 1

Hydromorphone
Drug
ActiveComparator Group · 1 Intervention: Hydromorphone · Intervention Types: Drug
Fentanyl
Drug
ActiveComparator Group · 1 Intervention: Fentanyl · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 48 hours post surgery

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,805 Previous Clinical Trials
2,278,405 Total Patients Enrolled
1 Trials studying Tonsillitis
47 Patients Enrolled for Tonsillitis
Michael Montana, MD PhDPrincipal InvestigatorWashington University School of Medicine

Eligibility Criteria

Age 2 - 15 · All Participants · 4 Total Inclusion Criteria

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