Clinical Trials Directory

Trials / Terminated

TerminatedNCT00763880

Hematoma Block as an Adjunct to Procedural Sedation for Forearm Fracture Reduction

Hematoma Blocks in Forearm Fractures: An Effective Adjunct to Procedural Sedation?

Status
Terminated
Phase
Phase 4
Study type
Interventional
Enrollment
89 (actual)
Sponsor
Rhode Island Hospital · Academic / Other
Sex
All
Age
3 Years – 17 Years
Healthy volunteers
Accepted

Summary

The purpose of our study is to determine if the use of a hematoma block together with intravenous sedation and analgesia is an effective means of managing forearm fractures in the Emergency Department. To determine this, we have designed a randomized, double-blind, placebo controlled trial of hematoma block versus saline for the manipulation of forearm fractures under conscious sedation with ketamine and midazolam. Our hypotheses are two-fold: First, the use of a hematoma block together with conscious sedation will allow for improved pain control. Second, the use of a hematoma block together with conscious sedation will allow us to use less sedation, therefore promoting faster recovery from sedation and more efficient patient turnover in the Emergency Department.

Conditions

Interventions

TypeNameDescription
DRUGLidocaine2% Lidocaine (no epinephrine) in the dose of 2.5 mg/kg to a maximum of 10mL will be instilled once into the fracture site in the form of a hematoma block.
DRUGSalineVolume of normal saline equivalent to providing 2.5mg/kg of 2% lidocaine, to a maximum of 10mL.

Timeline

Start date
2005-11-01
Primary completion
2008-09-01
Completion
2008-09-01
First posted
2008-10-01
Last updated
2013-11-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00763880. Inclusion in this directory is not an endorsement.