CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 120 enrolled
Drug / intervention
lidocaine (1%) + bupivacaine (0.5%) +2 moredrug
Likely dose
Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg)from 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/NCT00678379
NCT00678379Phase 3Completed
CompareCT.gov

Pediatric Tonsillectomy Pain Reduction Study, a Randomized, Placebo Controlled, Double-Blind Clinical Trial Using Clonidine and Local Anesthetics

Vanderbilt University Medical Center·interventional·Posted May 15, 2008·Updated Jul 2, 2017

In Brief

A Phase 3 clinical trial evaluating lidocaine (1%) + bupivacaine (0.5%), Normal saline, and 1 other intervention for Postoperative Pain. Completed, enrolled 120 participants across 1 site.

Detailed Summary

Tonsillectomy is associated with a significant decrease quality of life in children secondary to pain, which is worsened with swallowing. The objective of the current study is to conduct a prospective, double-blind, placebo-controlled, randomized clinical trial using a pre-tonsillectomy infiltration of the tonsillar fossa comparing three treatment regimens in reducing post-tonsillectomy morbidity (i.e. pain, poor oral intake): 1) Placebo (saline injection) 2) bupivacaine (0.5%) + lidocaine (1%), 3) bupivacaine (0.5%) + lidocaine (1%) + clonidine (25 µg).

Study Details

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

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 15, 2008
Enrollment StartApr 1, 2008
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.1 years ago

Interventions

lidocaine (1%) + bupivacaine (0.5%)drug

Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy. B - lidocaine (1%) + bupivacaine (0.5%)

Normal salinedrug

Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy. A - normal saline

Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg)drug

Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy. C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)