Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair

Completed · Not applicable

Conditions studied: Children, Lacerations, Procedures, Child, Pain

In brief

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

Key facts

Study ID

NCT01053637

Run by

Baylor College of Medicine

People needed

85

Starts

2009-02-01

Expected to finish

2015-05-01

Last updated by the study team

2021-08-25

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Baylor College of Medicine — Houston, Texas, 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.