CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 122 enrolled
Drug / intervention
dexmedetomidine +1 moredrug
Likely dose
dexmedetomidine 2 microgramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00468052
NCT00468052Phase 3Completed

Use of Dexmedetomidine Infusion for Analgesia and Emergence Agitation for Children Undergoing Tonsillectomy and Adenotonsillectomy

University of Medicine and Dentistry of New Jersey·interventional·Posted May 1, 2007·Updated Dec 5, 2016

In Brief

A Phase 3 clinical trial evaluating dexmedetomidine and fentanyl for Obstructive Sleep Apnea. Completed, enrolled 122 participants across 1 site.

Detailed Summary

Pediatric tonsillectomy (with or without adenoidectomy) is a brief but painful surgery carried out in children who very often also present with obstructive sleep apnea. To provide pain relief, i.e. analgesia, current practice relies on opioids , e.g., morphine or fentanyl. These narcotics are known to depress respiration and to increase the incidence of post-operative nausea and vomiting. These side effects are worrisome in this patient cohort. An alternative medication, dexmedetomidine, may have an opiate sparing effect and has a high safety profile in adults as well as in sedation in children. The purpose of this study is to determine if intravenous dexmedetomidine given as an infusion during general anesthesia for tonsillectomy or adenotonsillectomy reduces the incidence and severity of emergence agitation, improves analgesia and reduces nausea and vomiting in the 60 minutes following surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 1, 2007
Enrollment StartMar 1, 2007
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 19.2 years ago

Interventions

dexmedetomidinedrug

2 micrograms/kilogram as a bolus then 0.7 micrograms/kilogram infusion

fentanyldrug

1 microgram/kilogram as a bolus