CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 109 enrolled
Drug / intervention
Dexmedetomidine 0.75 mcg/kg +3 moredrug
Likely dose
Dexmedetomidine 0.75 mcg/kgfrom 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/NCT01057381
NCT01057381Phase 4Completed

Dose Response Relationship of Dexmedetomidine in Decreasing Post Operative Analgesic Requirements in the Pediatric Tonsillectomy Patient

Baylor College of Medicine·interventional·Posted Jan 27, 2010·Updated Jul 27, 2021

In Brief

A Phase 4 clinical trial evaluating Dexmedetomidine 0.75 mcg/kg, Morphine 50 mcg/kg, and 2 other interventions for Pediatric Adenotonsillectomy and Post Operative Analgesia. Completed, enrolled 109 participants across 1 site.

Detailed Summary

The hypothesis of this study is that the administration of an intra-operative dose of dexmedetomidine will result in adequate analgesia without respiratory depression thereby resulting in an early discharge from the post anesthetic care unit following adenotonsillectomy.

Study Details

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

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2010
Enrollment StartAug 1, 2005
Primary CompletionNov 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 16.4 years ago

Interventions

Dexmedetomidine 0.75 mcg/kgdrug

Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia.

Morphine 50 mcg/kgdrug

Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia

Morphine 100 mcg/kgdrug

Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia

Dexmedetomidine 1 mcg/kgdrug

Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia