CompletedNot Applicable

Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair

United States85 participantsStarted 2009-02

Plain-language summary

The purpose of this study is: * To determine whether oral narcotic medication versus placebo improves the pain and anxiety scores for pediatric patients requiring laceration repair in the pediatric emergency department and receiving the standard of care with lidocaine treatment * To evaluate for a statistical difference in pain scores in children during laceration repair * To evaluate for a statistical difference in State-Trait Anxiety Inventory for Children (STAIC) scores during laceration repair

Who can participate

Age range2 Years – 17 Years

SexALL

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: * Age 2 to 17 years * Laceration of the skin and/or subcutaneous tissue requiring sutures * American Society of Anesthesiologists (ASA) score of I or II Exclusion Criteria: * Major injuries in addition to laceration (suspected fracture, intracranial, intrathoracic, or intraabdominal bleeding or organ injury) * Abnormal neurologic examination (such as head injury) * Severe congenital heart disease * Pregnancy * Known opiate or acetaminophen allergy * Require conscious sedation * Have had narcotic or acetaminophen administration within 4 previous hours

What they're measuring

Statistical Difference in Pain Scores in Children During Laceration Repair Between Study and Placebo Group

Timeframe: 5 minutes

Trial details

NCT IDNCT01053637

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-01

Results submitted2016-05-27

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