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The Addition of Oral Analgesics to LET During Laceration Repair

This study is not yet open for participant recruitment.
Verified June 2012 by Children's Hospitals and Clinics of Minnesota
Sponsor:
Information provided by (Responsible Party):
Heidi Vander Velden, Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:
NCT01268670
First received: December 29, 2010
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
  Purpose

Background Approximately 30 million children are treated in emergency departments each year in the United States, of which two to three million are children presenting with lacerations. Topical numbing medication is the standard of care in children with regard to pain control during laceration repair. While topical numbing medications are effective, children often require further pain control during laceration repair in the form of an injected numbing medication, which in itself is painful. No evidence currently exists regarding the concurrent use of oral pain medications to combat laceration procedural pain.

Research Question Does the addition of ibuprofen or oxycodone to lidocaine, epinephrine, and tetracaine (LET) topical anesthetic provide more effective pain control than LET alone during laceration repair?

Design This is a double-blinded, randomized-controlled study.

Methods Subjects in all three groups will receive topical anesthetic. In addition to topical anesthetic, two groups of children will receive either of two oral analgesics, ibuprofen or oxycodone, while the third group will receive a placebo.


Condition Intervention
Laceration
Pain
 Drug: Ibuprofen
Drug: Oxycodone
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adjunctive Oral Analgesia for Laceration Repair: Assessing Pain in a Pediatric Emergency Department

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospitals and Clinics of Minnesota:

Primary Outcome Measures:
  • Pain scores [ Time Frame: At Triage, after first suture, and the worst during the procedure ] [ Designated as safety issue: No ]
    The use of adjunctive oral analgesics for facial/scalp laceration repair decrease pain scores more effectively than LET alone.


Estimated Enrollment: 150
Study Start Date: July 2012
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ibuprofen
Subjects will receive topical LET and oral ibuprofen.
 Drug: Ibuprofen
Subjects will receive topical LET and oral ibuprofen.
Active Comparator: Oxycodone
Subjects will receive topical LET and oral oxycodone.
 Drug: Oxycodone
Subjects will receive topical LET and oral oxycodone.
Placebo Comparator: Placebo
Subjects will receive topical LET and oral placebo.
 Other: Placebo
Subjects will receive topical LET and oral placebo.

  Eligibility

Ages Eligible for Study:   4 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English-speaking patients
  • Patients 4 years of age up to 10 years of age
  • Patients seen in the ED needing simple facial laceration repair
  • Patients with no chronic medical problems

Exclusion Criteria:

  • Any patient who's parent or primary caretaker refuses consent
  • Any patient who's parent or primary caretaker needs an interpreter
  • Any child with complex laceration(s) or bites
  • Any child who has received pain medication at home in response to the facial laceration.
  • Children needing procedural sedation
  • Children with a known allergy to lidocaine, epinephrine, tetracaine, ibuprofen, or oxycodone
  • Patients with known or pre-existing medical conditions where the study protocol cannot be used
  • This includes any patient with a medical condition that prevents appropriate use of the pain scale
  • It also includes patients with medical conditions that warrant the use of chronic medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268670

Locations
United States, Minnesota
Children's Hospitals and Clinics of Minnesota Not yet recruiting
Minneapolis and St Paul, Minnesota, United States
Contact: Thomas Skrypek, MD     612-813-6843        
Principal Investigator: Thomas Skrypek, MD            
Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
  More Information

No publications provided

Responsible Party: Heidi Vander Velden, Senior Clinical Research Coordinator, Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT01268670     History of Changes
Other Study ID Numbers: 1005-052
Study First Received: December 29, 2010
Last Updated: June 15, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries
Ibuprofen
Oxycodone
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Narcotics
Central Nervous System Depressants
Analgesics, Opioid

ClinicalTrials.gov processed this record on June 17, 2013