The Addition of Oral Analgesics to LET During Laceration Repair (NCT01268670) | Clinical Trial Compass
SuspendedNot Applicable
The Addition of Oral Analgesics to LET During Laceration Repair
Stopped: This study is currently suspended due to transition of the investigator.
United States150 participantsStarted 2012-07
Plain-language 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.
Who can participate
Age range
4 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is currently listed as suspended — do you know why it was suspended, and does that affect whether it would be safe or appropriate for me to consider participating?
2The study is looking at adding oral pain medications on top of a numbing gel called LET during laceration repair — based on what you know about this approach, do you think the combination would actually offer me meaningfully better pain control than LET alone?
3Since this trial is in a 'not applicable' phase and is measuring pain scores as its main outcome, how much do we already know about the safety of combining oral pain relievers with LET, and are there any risks I should be aware of?
4If this trial isn't currently enrolling, what pain management options are available to me right now for laceration repair that might achieve a similar goal of reducing discomfort during the procedure?
5How would my specific laceration — its size, location, or severity — affect whether a study like this would even be relevant to my situation, and is there a standard-of-care approach my care team would recommend instead?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain scores
Timeframe: At Triage, after first suture, and the worst during the procedure
Trial details
NCT IDNCT01268670
SponsorChildren's Hospitals and Clinics of Minnesota