Trial Outcomes & Findings for Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair (NCT NCT01053637)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

85 participants

Primary outcome timeframe

5 minutes

Results posted on

2021-08-25

Participant Flow

Participant milestones

Participant milestones
Measure	Hydrocodone/Acetaminophen 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.	Sugar Water 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
Overall Study STARTED	43	42
Overall Study COMPLETED	43	42
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=43 Participants Hydrocodone/acetaminophen suspension (taste/color-matched)	Placebo n=42 Participants Sugar solution	Total n=85 Participants Total of all reporting groups
Age, Continuous	5.25 years n=5 Participants	4.87 years n=7 Participants	5.1 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	16 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	26 Participants n=7 Participants	62 Participants n=5 Participants
Race/Ethnicity, Customized African-American	12 participants n=5 Participants	8 participants n=7 Participants	20 participants n=5 Participants
Race/Ethnicity, Customized Caucasian	4 participants n=5 Participants	10 participants n=7 Participants	14 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	25 participants n=5 Participants	23 participants n=7 Participants	48 participants n=5 Participants
Race/Ethnicity, Customized Other	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants	42 participants n=7 Participants	85 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 minutes

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Hydrocodone/Acetaminophen n=23 Participants 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.	Sugar Water n=22 Participants 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
Statistical Difference in Pain Scores in Children During Laceration Repair Between Study and Placebo Group	5 units on a scale Interval 4.0 to 6.5	7 units on a scale Interval 5.25 to 10.0

SECONDARY outcome

Timeframe: 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).

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Hydrocodone/Acetaminophen n=18 Participants 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.	Sugar Water n=16 Participants 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
Statistical Difference in State-Trait Anxiety Inventory for Children (STAIC) Scores for Children Aged 8-17 Years During Laceration Repair and VAS Pain Scale State Anxiety Pre-Test	34.5 units on a scale Interval 31.0 to 40.75	38.0 units on a scale Interval 32.5 to 41.75
Statistical Difference in State-Trait Anxiety Inventory for Children (STAIC) Scores for Children Aged 8-17 Years During Laceration Repair and VAS Pain Scale State Anxiety Post-Test	26.0 units on a scale Interval 24.0 to 30.0	29.0 units on a scale Interval 21.5 to 32.5
Statistical Difference in State-Trait Anxiety Inventory for Children (STAIC) Scores for Children Aged 8-17 Years During Laceration Repair and VAS Pain Scale VAS Pain Score at 5 minutes	0.1 units on a scale Interval 0.0 to 4.23	0.5 units on a scale Interval 0.0 to 1.2

SECONDARY outcome

Timeframe: 30 minutes

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Hydrocodone/Acetaminophen n=17 Participants 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.	Sugar Water n=14 Participants 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
Visual Analog Scale (VAS) Pain Score for Children > 7 Years. Baseline	0.5 score on a scale Interval 0.0 to 5.3	0.85 score on a scale Interval 0.0 to 4.85
Visual Analog Scale (VAS) Pain Score for Children > 7 Years. 5 minutes	0.1 score on a scale Interval 0.0 to 4.23	0.5 score on a scale Interval 0.0 to 1.2
Visual Analog Scale (VAS) Pain Score for Children > 7 Years. 10 minutes	0.0 score on a scale Interval 0.0 to 2.0	0.0 score on a scale Interval 0.0 to 1.6
Visual Analog Scale (VAS) Pain Score for Children > 7 Years. 15 minutes	0.0 score on a scale Interval 0.0 to 3.18	0.0 score on a scale Interval 0.0 to 0.75
Visual Analog Scale (VAS) Pain Score for Children > 7 Years. Procedure Finish	0.0 score on a scale Interval 0.0 to 0.0	0.0 score on a scale Interval 0.0 to 0.0

Adverse Events

Hydrocodone/Acetaminophen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sugar Water

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Corrie E. Chumpitazi

BAYLOR COLLEGE OF MEDICINE

Phone: 832 824-1353

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place