NCT01053637

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 21, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

August 25, 2021

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

2.9 years

First QC Date

January 20, 2010

Results QC Date

May 27, 2016

Last Update Submit

August 2, 2021

Conditions

ChildrenLacerationsProceduresChildPain

Keywords

lacerationssuturespediatricschildpainAnxiety

Outcome Measures

Primary Outcomes (1)

  • Statistical Difference in Pain Scores in Children During Laceration Repair Between Study and Placebo Group

    Children's Hospital of Eastern Ontario Pain Scale, for children 2-7 years. This score ranks 6 categories: Cry, Facial expression, Verbal Response, Torso movement, Touch, and Leg movement. The scale varies by each category from 0-2 or 1-2 or 1-3; such that a minimum score is 4 (no pain) and a maximum score is 13 signifying greatest pain. This results in a 10 point scale of possible results, and is rated by an objective observer; the child life specialist at the bedside during the laceration repair. If the procedure was completed, there were no scores recorded at that time point.

    5 minutes

Secondary Outcomes (2)

  • Statistical Difference in State-Trait Anxiety Inventory for Children (STAIC) Scores for Children Aged 8-17 Years During Laceration Repair and VAS Pain Scale

    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).

  • Visual Analog Scale (VAS) Pain Score for Children > 7 Years.

    30 minutes

Study Arms (2)

Hydrocodone/acetaminophen

EXPERIMENTAL

Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone.

Drug: hydrocodone/acetaminophen

Sugar water

PLACEBO COMPARATOR

Placebo

Drug: Sugar water

Interventions

hydrocodone/acetaminophenDRUG

0.17 mg/kg hydrocodone component to max of 10 mg. If dose is vomited within 5 minutes, second dose may be administered.

Also known as: Lortab, Vicodin
Hydrocodone/acetaminophen
Sugar waterDRUG

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

Sugar water

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

LacerationsPainAnxiety Disorders

Interventions

oxycodone-acetaminophenacetaminophen, hydrocodone drug combination

Condition Hierarchy (Ancestors)

Wounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Results Point of Contact

Title
Corrie E. Chumpitazi
Organization
BAYLOR COLLEGE OF MEDICINE
corriec@bcm.edu
832 824-1353

Study Officials

  • Corrie Chumpitazi, MD

    Texas Childrens Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 20, 2010

First Posted

January 21, 2010

Study Start

February 1, 2009

Primary Completion

January 1, 2012

Study Completion

May 1, 2015

Last Updated

August 25, 2021

Results First Posted

August 25, 2021

Record last verified: 2021-08

Locations

US(1)