Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Corrie Chumpitazi, Texas Children's Hospital

ClinicalTrials.gov Identifier:

NCT01053637

First received: January 20, 2010

Last updated: June 1, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 20, 2010

Last Updated Date

June 1, 2012

Start Date ^ICMJE

February 2009

Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Statistical difference in pain scores in children during laceration repair between study and placebo group [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01053637 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Statistical difference in State-Trait Anxiety Inventory for Children (STAIC) scores for children age 8-17 years during laceration repair [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Statistical difference in State-Trait Anxiety Inventory for Children (STAIC) scores for children age 8-17 years during laceration repair [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair

Official Title ^ICMJE

Randomized Control Trial of Oral Narcotic Medication for Pain and Anxiety Management During Laceration Repair in the Pediatric Emergency Department

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Pediatrics
Lacerations
Sutures
Child
Pain

Intervention ^ICMJE

Drug: hydrocodone/acetaminophen
0.17 mg/kg hydrocodone component to max of 10 mg. If dose is vomited within 5 minutes, second dose may be administered.
Other Names:
- Lortab
- Vicodin
Drug: Sugar water
An equal volume of sugar water will be dispensed, as for the weight based 0.17 mg/kg hydrocodone solution given for the study drug

Study Arm (s)

Experimental: Hydrocodone/acetaminophen
Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone.

Intervention: Drug: hydrocodone/acetaminophen
Placebo Comparator: Sugar water
Intervention: Drug: Sugar water

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2012

Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

2 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01053637

Other Study ID Numbers ^ICMJE

H-22684

Has Data Monitoring Committee

Responsible Party

Corrie Chumpitazi, Texas Children's Hospital

Study Sponsor ^ICMJE

Texas Children's Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Corrie Chumpitazi, MD

Texas Childrens Hospital

Information Provided By

Texas Children's Hospital

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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