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

Ketamine

Brief 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.

Intervention / Treatment

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

Condition or Disease

  • Forearm Fracture

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 3 Years to 17 Years
    Enrollment: 89 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Nov 01, 2005
    Primary Completion: Sep 01, 2008 ACTUAL
    Completion Date: Sep 01, 2008 ACTUAL
    Study First Posted: Oct 01, 2008 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Nov 18, 2013

    Sponsors / Collaborators

    Lead Sponsor: Rhode Island Hospital
    Responsible Party: N/A

    Location

    Providence, Rhode Island, USA

    Participant Groups

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

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

    Eligibility Criteria

    Sex: All
    Minimum Age: 3
    Maximum Age: 17
    Age Groups: Child
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • Total sedation time Evaluated upon completion of procedure
    Secondary Outcomes
    • Non-union 1 month
    • Need for re-manipulation 1 week
    • Adverse effects of sedation For the duration of the procedure
    • Adverse effects of hematoma block 1 month
    • Pain control For entire duration of procedure

    More Details

    NCT Number: NCT00763880
    Other IDs: CMTT # 4040-05
    Study URL: https://clinicaltrials.gov/study/NCT00763880
    Last updated: Sep 29, 2023