Clinical trial NCT01053637: Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair
Official title: Randomized Control Trial of Oral Narcotic Medication for Pain and Anxiety Management During Laceration Repair in the Pediatric Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children
Lacerations
Procedures
Child
Pain
Keywords: lacerations
sutures
pediatrics
child
pain
Anxiety
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2010-01-21
Enrollment: 85
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: A prospective, double-blind, placebo-controlled, randomized clinical trial in a tertiary care pediatric emergency department with an annual census of 80,000 visits per year. Patients will be randomized by a randomization table with block randomization in the pharmacy to the oral narcotic or placebo group, and the pharmacist will be the only person aware of the randomization status of the patient. Allocation concealment will be ensured by opaque, sealed envelopes kept in the Emergency Department Pharmacy. Guardians of patients age 2 to 17 years of age will be consented for enrollment.

Eligibility criteria: 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

Primary outcomes:
measure: Statistical Difference in Pain Scores in Children During Laceration Repair Between Study and Placebo Group
timeFrame: 5 minutes
Secondary outcomes:
measure: Statistical Difference in State-Trait Anxiety Inventory for Children (STAIC) Scores for Children Aged 8-17 Years During Laceration Repair and VAS Pain Scale
timeFrame: 1 hour approximately (survey was given pre and post procedure so from 15 minutes to 1 hour after initial survey (or 5 minutes to 45 minutes after the procedure).
measure: Visual Analog Scale (VAS) Pain Score for Children > 7 Years.
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Texas Childrens Hospital
name: Corrie Chumpitazi, MD
role: PRINCIPAL_INVESTIGATOR
References: