The Addition of Oral Analgesics to LET During Laceration Repair

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01268670
• Other study ID #: 1005-052
• Status: Suspended
• Phase: N/A
• First received: December 29, 2010
• Last updated: July 30, 2013
• Start date: July 2012

Study information

• Verified date: July 2013
• Source: Children's Hospitals and Clinics of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 150
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 10 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laceration
• Lacerations
• Pain

Intervention

Drug:
• Ibuprofen
Subjects will receive topical LET and oral ibuprofen.
• Oxycodone
Subjects will receive topical LET and oral oxycodone.

Other:
• Placebo
Subjects will receive topical LET and oral placebo.

Locations

Country	Name	City	State
United States	Children's Hospitals and Clinics of Minnesota	Minneapolis and St Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospitals and Clinics of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No