Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Texas Children's Hospital.
Recruitment status was  Active, not recruiting
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
  Purpose

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

Condition Intervention
Pediatrics
Lacerations
Sutures
Child
Pain
Drug: hydrocodone/acetaminophen
Drug: Sugar water

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Control Trial of Oral Narcotic Medication for Pain and Anxiety Management During Laceration Repair in the Pediatric Emergency Department

Resource links provided by NLM:


Further study details as provided by Texas Children's Hospital:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 85
Study Start Date: February 2009
Estimated Study Completion Date: November 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydrocodone/acetaminophen
Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone.
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
Placebo Comparator: Sugar water 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

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

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053637

Locations
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Texas Children's Hospital
Investigators
Principal Investigator: Corrie Chumpitazi, MD Texas Childrens Hospital
  More Information

No publications provided

Responsible Party: Corrie Chumpitazi, Assistant Professor, Texas Children's Hospital
ClinicalTrials.gov Identifier: NCT01053637     History of Changes
Other Study ID Numbers: H-22684
Study First Received: January 20, 2010
Last Updated: June 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Children's Hospital:
lacerations
sutures
pediatrics
child
pain
Anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Lacerations
Mental Disorders
Wounds and Injuries
Acetaminophen
Acetaminophen, hydrocodone drug combination
Hydrocodone
Oxycodone
Narcotics
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 29, 2014