Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair

• Sponsor: Baylor College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT01053637
• Collaborator: (none)
• Enrollment: 85
• Location: 1
• Arms: 2
• Duration (Months): 74.9
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Children; Lacerations; Procedures; Child; Pain	Drug: hydrocodone/acetaminophen; Drug: Sugar water	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 85 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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 Placebo	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

Outcome Measures

Primary Outcome Measures

1. Statistical Difference in Pain Scores in Children During Laceration Repair Between Study and Placebo Group [5 minutes]

   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.

Secondary Outcome Measures

1. 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).]

   State-Trait Anxiety Inventory for Children - 20 questions with 3 answer options for each question. Scores range from 20 to 60 for state and 20 to 60 for trait with 60 being the higher (more or worse) anxiety on self-assessment. The VAS pain Scale from 0-10 was included in this older population as well.

2. Visual Analog Scale (VAS) Pain Score for Children > 7 Years. [30 minutes]

   Visual Analog Scale from 0-10 as marked on a 10 cm line. 0 no pain, 10 worst pain. A child >7 group marks their pain on the line, and a mm measurement is made. Power based on a change in the Visual Analog Scale (VAS) for children > 7 years. A change in pain score of 10 mm (95% Confidence Interval 7-12 mm) was considered to be clinically significant based upon a previous study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Baylor College of Medicine	Houston	Texas	United States	77030

Sponsors and Collaborators

• Baylor College of Medicine

Investigators

• Principal Investigator: Corrie Chumpitazi, MD, Texas Childrens Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Corrie Chumpitazi, Assistant Professor, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT01053637
• Other Study ID Numbers: H-22684
• First Posted: Jan 21, 2010
• Last Update Posted: Aug 25, 2021
• Last Verified: Aug 1, 2021

• Keywords provided by Corrie Chumpitazi, Assistant Professor, Baylor College of Medicine: lacerations; sutures; pediatrics; child; pain; Anxiety
• Additional relevant MeSH terms: Lacerations; Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone

Study Results

Participant Flow

Arm/Group Title	Hydrocodone/Acetaminophen	Sugar Water
Arm/Group Description	Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone. 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.	Placebo 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
Period Title: Overall Study
STARTED	43	42
COMPLETED	43	42
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intervention	Placebo	Total
Arm/Group Description	Hydrocodone/acetaminophen suspension (taste/color-matched)	Sugar solution	Total of all reporting groups
Overall Participants	43	42	85
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	5.25	4.87	5.1
Sex: Female, Male (Count of Participants)
Female	7 16.3%	16 38.1%	23 27.1%
Male	36 83.7%	26 61.9%	62 72.9%
Race/Ethnicity, Customized (participants) [Number]
African-American	12 27.9%	8 19%	20 23.5%
Caucasian	4 9.3%	10 23.8%	14 16.5%
Hispanic	25 58.1%	23 54.8%	48 56.5%
Other	2 4.7%	1 2.4%	3 3.5%
Region of Enrollment (participants) [Number]
United States	43 100%	42 100%	85 100%

Outcome Measures

1. Primary Outcome

Title	Statistical Difference in Pain Scores in Children During Laceration Repair Between Study and Placebo Group
Description	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.
Time Frame	5 minutes

Outcome Measure Data

Analysis Population Description

The 2-7 year old population at primary outcome time point of 5 minutes. This 2-7 year old population: randomized 25 in each arm (50 total) but 5 had missing pain scores due to child life specialist availability at the time of repair. Older population had 35 patients enrolled, but 1 in the placebo group was excluded for missing pain scores.

Arm/Group Title	Hydrocodone/Acetaminophen	Sugar Water
Arm/Group Description	Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone. 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.	Placebo 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
Measure Participants	23	22
Median (Inter-Quartile Range) [units on a scale]	5	7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hydrocodone/Acetaminophen, Sugar Water
	Comments	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 or worst pain.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments	Pain at 5 minutes using Children's Hospital of Eastern Ontario Pain Scale validated in the younger population. Using a 2-point difference in CHEOPS pain scale as a clinically significant change, 34 patients were required in the younger 2- to 7 group.
	Method	Fisher Exact
	Comments

2. Secondary Outcome

Title	Statistical Difference in State-Trait Anxiety Inventory for Children (STAIC) Scores for Children Aged 8-17 Years During Laceration Repair and VAS Pain Scale
Description	State-Trait Anxiety Inventory for Children - 20 questions with 3 answer options for each question. Scores range from 20 to 60 for state and 20 to 60 for trait with 60 being the higher (more or worse) anxiety on self-assessment. The VAS pain Scale from 0-10 was included in this older population as well.
Time Frame	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).

Outcome Measure Data

Analysis Population Description

State-Trait Anxiety Inventory for Children (STAIC) which is a 20 question tool, low score no anxiety and high score more anxiety. This test was only used for the 34 patients in the >7 years (8-17 years) category as this scale is validated in that population. The VAS Pain score was measured as well.

Arm/Group Title	Hydrocodone/Acetaminophen	Sugar Water
Arm/Group Description	Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone. 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.	Placebo 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
Measure Participants	18	16
State Anxiety Pre-Test	34.5	38.0
State Anxiety Post-Test	26.0	29.0
VAS Pain Score at 5 minutes	0.1	0.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hydrocodone/Acetaminophen, Sugar Water
	Comments	State-Trait Anxiety Inventory for Children pre vs. post procedure for matched pairs. Higher numbers indicated higher state anxiety. State Trait Anxiety Inventory for Children (STAIC) scores pre vs. post procedure for matched pairs. A lower STAIC score indicates less anxiety and a greater score indicates more anxiety based on Likert-type scales and analyzed using nonparametric testing.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

Title	Visual Analog Scale (VAS) Pain Score for Children > 7 Years.
Description	Visual Analog Scale from 0-10 as marked on a 10 cm line. 0 no pain, 10 worst pain. A child >7 group marks their pain on the line, and a mm measurement is made. Power based on a change in the Visual Analog Scale (VAS) for children > 7 years. A change in pain score of 10 mm (95% Confidence Interval 7-12 mm) was considered to be clinically significant based upon a previous study.
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

1 placebo (sugar water) patient required sedation and 1 placebo (sugar water) patient had missing pain scores, so 14 patients for analysis. For the hydrocodone/acetaminophen group, baseline VAS score was not available for 1 participant. If the procedure was completed, there were no scores recorded at that time point (i.e. 20 minutes).

Arm/Group Title	Hydrocodone/Acetaminophen	Sugar Water
Arm/Group Description	Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone. 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.	Placebo 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
Measure Participants	17	14
Baseline	0.5	0.85
5 minutes	0.1	0.5
10 minutes	0.0	0.0
15 minutes	0.0	0.0
Procedure Finish	0.0	0.0

Adverse Events

Time Frame	Adverse events were collected from the time of enrollment through hospital discharge for the specific emergency department visit during which the patient was enrolled, and chart reviewed for return visit up to 72 hours from discharge.
Adverse Event Reporting Description	Any adverse event was reported directly to the study PI.
Arm/Group Title	Hydrocodone/Acetaminophen		Sugar Water
Arm/Group Description	Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone. 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.		Placebo 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
All Cause Mortality
	Hydrocodone/Acetaminophen		Sugar Water
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/42 (0%)
Serious Adverse Events
	Hydrocodone/Acetaminophen		Sugar Water
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/42 (0%)
Other (Not Including Serious) Adverse Events
	Hydrocodone/Acetaminophen		Sugar Water
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/42 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.