The Addition of Oral Analgesics to LET During Laceration Repair

NCT01268670 | Suspended

• 1 other identifier: 1005-052
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laceration; Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Ibuprofen

ACTIVE COMPARATOR

Subjects will receive topical LET and oral ibuprofen.

Drug: Ibuprofen

Oxycodone

ACTIVE COMPARATOR

Subjects will receive topical LET and oral oxycodone.

Drug: Oxycodone

Placebo

PLACEBO COMPARATOR

Subjects will receive topical LET and oral placebo.

Other: Placebo

Interventions

Ibuprofen DRUG

Subjects will receive topical LET and oral ibuprofen.

Ibuprofen

Oxycodone DRUG

Subjects will receive topical LET and oral oxycodone.

Oxycodone

Placebo OTHER

Subjects will receive topical LET and oral placebo.

Placebo

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospitals and Clinics of Minnesota: lead

Study Sites (1)

Children's Hospitals and Clinics of Minnesota

Minneapolis and Saint Paul, Minnesota, United States

Location

MeSH Terms

Conditions

Lacerations; Pain

Interventions

Ibuprofen; Oxycodone

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Research Coordinator

Study Record Dates

• First Submitted: December 29, 2010
• First Posted: December 31, 2010
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Last Updated: July 31, 2013

Record last verified: 2013-07

Locations

US (1)