Laceration, Pain
Conditions
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.
Interventions
DRUGIbuprofen
Subjects will receive topical LET and oral ibuprofen.
DRUGOxycodone
Subjects will receive topical LET and oral oxycodone.
OTHERPlacebo
Subjects will receive topical LET and oral placebo.
Sponsors
Children's Hospitals and Clinics of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores | At Triage, after first suture, and the worst during the procedure | The use of adjunctive oral analgesics for facial/scalp laceration repair decrease pain scores more effectively than LET alone. |
Countries
United States
Outcome results
None listed