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

NCT ID: NCT00763880

Last Updated: 2013-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Forearm Fracture

Keywords

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Hematoma block Lidocaine Forearm fracture Radius fracture Ulna fracture Ketamine Midazolam Procedural sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Lidocaine

Subjects randomly assigned to this arm will receive 2% lidocaine by injection into their fracture site in the form of a hematoma block.

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

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.

Normal Saline

Subjects randomly assigned to this arm will receive normal saline by injection into their fracture site

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Volume of normal saline equivalent to providing 2.5mg/kg of 2% lidocaine, to a maximum of 10mL.

Interventions

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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.

Intervention Type DRUG

Saline

Volume of normal saline equivalent to providing 2.5mg/kg of 2% lidocaine, to a maximum of 10mL.

Intervention Type DRUG

Other Intervention Names

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Xylocaine Lidocaine hydrochloride Sodium Chloride

Eligibility Criteria

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Inclusion Criteria

* English or Spanish speaking
* Ages 3-17
* Closed distal forearm fracture requiring reduction under sedation in the Emergency Department
* Fracture involves the distal third of the forearm

Exclusion Criteria

* Multiple trauma victims
* Associated nerve or vascular damage
* Associated elbow or humerus injury
* Sensitivity or allergy to lidocaine
* Contraindications to procedural sedation
* Previous attempts at reduction for the same injury
Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rhode Island Hospital

OTHER

Sponsor Role lead

Responsible Party

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Erika Constantine

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erika Constantine, MD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Locations

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Hasbro Children's Hospital/Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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CMTT # 4040-05

Identifier Type: -

Identifier Source: org_study_id