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
| Type | Name | Description |
|---|---|---|
| DRUG | Lidocaine | 2% 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. |
| DRUG | Saline | Volume 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.