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Opioid

Short acting opioids: Fentanyl/Hydromorphone for Sleep Apnea

Phase 4
Waitlist Available
Led By Lisa M. Einhorn, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Age \>= 3 and \< 18 years
2. Elective tonsillectomy +/- adenoidectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 days post surgery
Awards & highlights

Summary

The purpose of this study is to compare the use of short acting opioids (fentanyl/hydromorphone) with long acting opioids (methadone) for pain control following tonsillectomy surgery in children and adolescents.

Eligible Conditions
  • Tonsillar Enlargement
  • Sleep Apnea
  • Postoperative Pain
  • Tonsillitis
  • Pediatric Sleep Apnea

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 days post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 days post surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants who required rescue opioid administration in the PACU (post-anesthesia care unit)
Secondary study objectives
Evaluation of participant's pain as measured by Numeric Pain Rating Scale
Number of participants with adverse event in the PACU (post-anesthesia care unit)
Opioid administration in the PACU (post-anesthesia care unit)
+2 more

Trial Design

2Treatment groups
Active Control
Group I: Short acting opioids: Fentanyl/HydromorphoneActive Control1 Intervention
Per Routine Care
Group II: Long acting opioid: MethadoneActive Control1 Intervention
Initial Dosing: 0.15 mg/kg age-ideal body weight in children age 3 - \< 12 years and 0.2 mg/kg age-ideal body weight in adolescents age 12 - 17 years. Dose escalation (possible, based on interim analysis): 0.2 mg/kg age-ideal body weight in children age 3 - \< 12 years and 0.25 mg/kg age-ideal body weight in adolescents age 12 - 17 years.

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Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,742 Previous Clinical Trials
7,511,957 Total Patients Enrolled
2 Trials studying Sleep Apnea
69 Patients Enrolled for Sleep Apnea
Duke UniversityLead Sponsor
2,398 Previous Clinical Trials
3,059,828 Total Patients Enrolled
Lisa M. Einhorn, MDPrincipal InvestigatorDuke University
~293 spots leftby Sep 2029
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