The Addition of Oral Analgesics to LET During Laceration Repair

Adjunctive Oral Analgesia for Laceration Repair: Assessing Pain in a Pediatric Emergency Department

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.

Study Overview

• Status: Suspended
• Conditions: Pain; Laceration
• Intervention / Treatment: Drug: Ibuprofen; Drug: Oxycodone; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis and St Paul, Minnesota, United States
      • Children's Hospitals and Clinics of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	The use of adjunctive oral analgesics for facial/scalp laceration repair decrease pain scores more effectively than LET alone.	At Triage, after first suture, and the worst during the procedure

Collaborators and Investigators

• Sponsor: Children's Hospitals and Clinics of Minnesota

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: December 29, 2010
• First Submitted That Met QC Criteria: December 29, 2010
• First Posted (Estimate): December 31, 2010

Study Record Updates

• Last Update Posted (Estimate): July 31, 2013
• Last Update Submitted That Met QC Criteria: July 30, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Ibuprofen; Oxycodone
• Other Study ID Numbers: 1005-052