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
Effectiveness Progress
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: DrugFentanyl
Drug
ActiveComparator Group · 1 Intervention: Fentanyl · Intervention Types: DrugTrial 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
Mark “Yes” if the following statements are true for you:References
- Friedman, Norman R., Jonathan N. Perkins, Bryan McNair, and Ron B. Mitchell. 2013. “Current Practice Patterns for Sleep-disordered Breathing in Children”. The Laryngoscope. Wiley. doi:10.1002/lary.23709.
- Brown, Karen A.. 2011. “Outcome, Risk, and Error and the Child with Obstructive Sleep Apnea”. Pediatric Anesthesia. Wiley. doi:10.1111/j.1460-9592.2011.03597.x.
- Bhattacharyya, Neil, and Harrison W. Lin. 2010. “Changes and Consistencies in the Epidemiology of Pediatric Adenotonsillar Surgery, 1996–2006”. Otolaryngology–head and Neck Surgery. SAGE Publications. doi:10.1016/j.otohns.2010.06.918.
- Brown KA. Outcome, risk, and error and the child with obstructive sleep apnea. Paediatr Anaesth. 2011 Jul;21(7):771-80. doi: 10.1111/j.1460-9592.2011.03597.x. Epub 2011 May 3.
- 2020. "Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04230681.
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Conditions
Cancer Related
Treatments