The Addition of Oral Analgesics to LET During Laceration Repair
Paused · Not applicable · Has a placebo group
Conditions studied: Laceration, Pain
In brief
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.
Key facts
- Study ID
- NCT01268670
- Run by
- Children's Hospitals and Clinics of Minnesota
- People needed
- 150
- Starts
- 2012-07-01
- Last updated by the study team
- 2013-07-31
Who can join
Age: 4 and older, up to 10. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Children's Hospitals and Clinics of Minnesota — Minneapolis and Saint Paul, Minnesota, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.