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Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair

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ClinicalTrials.gov Identifier: NCT01053637
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : May 13, 2015
Sponsor:
Information provided by (Responsible Party):
Corrie Chumpitazi, Baylor College of Medicine

Tracking Information
First Submitted Date  ICMJE January 20, 2010
First Posted Date  ICMJE January 21, 2010
Last Update Posted Date May 13, 2015
Study Start Date  ICMJE February 2009
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2010)
Statistical difference in pain scores in children during laceration repair between study and placebo group [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2012)
Statistical difference in State-Trait Anxiety Inventory for Children (STAIC) scores for children age 8-17 years during laceration repair [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2010)
Statistical difference in State-Trait Anxiety Inventory for Children (STAIC) scores for children age 8-17 years during laceration repair [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Children
  • Lacerations
  • Procedures
  • 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 Arms  ICMJE
  • 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
    Placebo
    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 Completed
Actual Enrollment  ICMJE
 (submitted: June 1, 2012)
85
Original Estimated Enrollment  ICMJE
 (submitted: January 20, 2010)
68
Actual Study Completion Date  ICMJE May 2015
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01053637
Other Study ID Numbers  ICMJE H-22684
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Corrie Chumpitazi, Baylor College of Medicine
Study Sponsor  ICMJE Baylor College of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Corrie Chumpitazi, MD Texas Childrens Hospital
PRS Account Baylor College of Medicine
Verification Date May 2015

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