Hematoma Block as an Adjunct to Procedural Sedation for Forearm Fracture Reduction - Full Text View

Sponsor:	Rhode Island Hospital
Information provided by:	Rhode Island Hospital
ClinicalTrials.gov Identifier:	NCT00763880

Purpose

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.

Condition	Intervention	Phase
Forearm Fracture	Drug: Lidocaine Drug: Saline	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Hematoma Blocks in Forearm Fractures: An Effective Adjunct to Procedural Sedation?

Resource links provided by NLM:

MedlinePlus related topics: Fractures

Drug Information available for: Lidocaine

U.S. FDA Resources

Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:

Total sedation time [ Time Frame: Evaluated upon completion of procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Non-union [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Need for re-manipulation [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
Adverse effects of sedation [ Time Frame: For the duration of the procedure ] [ Designated as safety issue: Yes ]
Adverse effects of hematoma block [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Pain control [ Time Frame: For entire duration of procedure ] [ Designated as safety issue: No ]

Enrollment:	89
Study Start Date:	November 2005
Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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: Placebo Comparator Subjects randomly assigned to this arm will receive normal saline by injection into their fracture site	Drug: Saline Volume of normal saline equivalent to providing 2.5mg/kg of 2% lidocaine, to a maximum of 10mL.

Eligibility

Ages Eligible for Study:	3 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763880

Locations

United States, Rhode Island
Hasbro Children's Hospital/Rhode Island Hospital
Providence, Rhode Island, United States, 02903

Sponsors and Collaborators

Rhode Island Hospital

Investigators

Principal Investigator:

Erika Constantine, MD

Rhode Island Hospital

More Information

No publications provided

Responsible Party:	Rhode Island Hospital ( Erika Constantine, MD )
Study ID Numbers:	CMTT # 4040-05
Study First Received:	September 26, 2008
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00763880 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:

Hematoma block
Lidocaine
Forearm fracture
Radius fracture

Ulna fracture
Ketamine
Midazolam
Procedural sedation

Additional relevant MeSH terms:

Fractures, Bone
Physiological Effects of Drugs
Wounds and Injuries
Lidocaine
Disorders of Environmental Origin
Anesthetics
Central Nervous System Depressants
Cardiovascular Agents
Hemorrhage

Anesthetics, Local
Pharmacologic Actions
Hematoma
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010