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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

January 20, 2010
June 1, 2012
February 2009
January 2012   (final data collection date for primary outcome measure)
Statistical difference in pain scores in children during laceration repair between study and placebo group [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01053637 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair
Randomized Control Trial of Oral Narcotic Medication for Pain and Anxiety Management During Laceration Repair in the Pediatric Emergency Department

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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Pediatrics
  • Lacerations
  • Sutures
  • Child
  • Pain
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
85
November 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
2 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01053637
H-22684
No
Corrie Chumpitazi, Texas Children's Hospital
Texas Children's Hospital
Not Provided
Principal Investigator: Corrie Chumpitazi, MD Texas Childrens Hospital
Texas Children's Hospital
June 2012

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