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

Forearm Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00763880
• Other study ID #: CMTT # 4040-05
• Status: Terminated
• Phase: Phase 4
• First received: September 26, 2008
• Last updated: November 18, 2013
• Start date: November 2005
• Est. completion date: September 2008

Study information

• Verified date: November 2013
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 89
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Forearm Fracture
• Fractures, Bone
• Hematoma

Intervention

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

Locations

Country	Name	City	State
United States	Hasbro Children's Hospital/Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total sedation time		Evaluated upon completion of procedure
Secondary	Non-union		1 month
Secondary	Need for re-manipulation		1 week
Secondary	Adverse effects of sedation		For the duration of the procedure
Secondary	Adverse effects of hematoma block		1 month
Secondary	Pain control		For entire duration of procedure