NCT00763880

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
Last Updated

November 19, 2013

Status Verified

November 1, 2013

Enrollment Period

2.8 years

First QC Date

September 26, 2008

Last Update Submit

November 18, 2013

Conditions

Forearm Fracture

Keywords

Hematoma blockLidocaineForearm fractureRadius fractureUlna fractureKetamineMidazolamProcedural sedation

Outcome Measures

Primary Outcomes (1)

  • Total sedation time

    Evaluated upon completion of procedure

Secondary Outcomes (5)

  • 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

Study Arms (2)

Lidocaine

EXPERIMENTAL

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

Drug: Lidocaine

Normal Saline

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

LidocaineDRUG

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.

Also known as: Xylocaine, Lidocaine hydrochloride
Lidocaine
SalineDRUG

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

Also known as: Sodium Chloride
Normal Saline

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasbro Children's Hospital/Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Radius FracturesUlna Fractures

Interventions

LidocaineSodium Chloride

Condition Hierarchy (Ancestors)

Forearm InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Erika Constantine, MD

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

September 26, 2008

First Posted

October 1, 2008

Study Start

November 1, 2005

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

November 19, 2013

Record last verified: 2013-11

Locations

US(1)