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

Lifespan

Status and phase: Terminated; Phase 4

Conditions: Forearm Fracture

Treatments: Drug: Saline; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT00763880

CMTT # 4040-05

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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89 participants in 2 patient groups, including a placebo group

Lidocaine

Experimental group

Description:

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

Treatment:

Drug: Lidocaine

Normal Saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline