Trial Outcomes & Findings for Acetaminophen and Post Circumcision Pain Control (NCT NCT02498483)

Last Updated: 2019-06-18

Results Overview

The Neonatal Infant Pain Scale (NIPS) is a behavioral scale and can be utilized with both full-term and pre-term infants. The tool uses the behaviors that nurses have described as being indicative of infant pain or distress. It is composed of six (6) indicators: facial expression, cry, breathing patterns, arms, legs and state of arousal. Each behavioral indicator is scored with 0 or 1 except "cry", which has three possible descriptors therefore, being scored with a 0, 1 or 2. Infants are observed for one minute in order to fully assess each indicator. Total pain scores range from 0-7, with a score of 0-2 indicating mild to no pain and no suggested intervention (better outcome) to a score \>4 indicating severe pain, suggesting non-pharmacological and/or pharmacological interventions may be needed.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

11 participants

Primary outcome timeframe

Baseline and 4 hours

Results posted on

2019-06-18

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Arm Includes subjects who received acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision.	Control Arm Includes subjects who received routine care post circumcision.
Overall Study STARTED	6	5
Overall Study COMPLETED	6	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acetaminophen and Post Circumcision Pain Control

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline and 4 hours

Outcome measures

Outcome measures
Measure	Acetaminophen Arm n=6 Participants Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision. Acetaminophen: Infants will receive 15 mg/kg of acetaminophen.	Non-treatment Arm n=5 Participants Routine circumcision without acetaminophen.
Neonatal Infant Pain Scale (NIPS) Baseline	2.5 score on a scale Interval 0.0 to 7.0	3.2 score on a scale Interval 0.0 to 6.0
Neonatal Infant Pain Scale (NIPS) 4 Hours post-circumcision	1.0 score on a scale Interval 0.0 to 2.0	1.4 score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: Baseline and 4 hours

Outcome measures

Outcome measures
Measure	Acetaminophen Arm n=6 Participants Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision. Acetaminophen: Infants will receive 15 mg/kg of acetaminophen.	Non-treatment Arm n=5 Participants Routine circumcision without acetaminophen.
Heart Rate Baseline	138.7 Beats per minute Interval 120.0 to 156.0	128.8 Beats per minute Interval 108.0 to 179.0
Heart Rate 4 Hours post-circumcision	125 Beats per minute Interval 116.0 to 136.0	124.8 Beats per minute Interval 101.0 to 150.0

SECONDARY outcome

Timeframe: Baseline and 4 hours

Population: Only subjects who were able to provide saliva were incorporated into the data analysis. One subject in the acetaminophen arm could not provide a saliva sample for analysis, and 2 subjects in the control arm could not provide saliva samples for analysis.

Outcome measures

Outcome measures
Measure	Acetaminophen Arm n=5 Participants Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision. Acetaminophen: Infants will receive 15 mg/kg of acetaminophen.	Non-treatment Arm n=3 Participants Routine circumcision without acetaminophen.
Change in Salivary Cortisol Rise Baseline	0.389 nmol/L Interval 0.159 to 0.917	0.427 nmol/L Interval 0.171 to 0.721
Change in Salivary Cortisol Rise 30 minutes post-circumcision	1.085 nmol/L Interval 0.439 to 2.779	0.811 nmol/L Interval 0.702 to 0.925

SECONDARY outcome

Timeframe: Baseline and 4 hours

Outcome measures

Outcome measures
Measure	Acetaminophen Arm n=6 Participants Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision. Acetaminophen: Infants will receive 15 mg/kg of acetaminophen.	Non-treatment Arm n=5 Participants Routine circumcision without acetaminophen.
Respiratory Rate 4 Hours post-circumcision	42 breaths per minute Interval 28.0 to 58.0	43.6 breaths per minute Interval 40.0 to 56.0
Respiratory Rate Baseline	59.7 breaths per minute Interval 40.0 to 94.0	45 breaths per minute Interval 40.0 to 52.0

SECONDARY outcome

Timeframe: Baseline 4 hours

Outcome measures

Outcome measures
Measure	Acetaminophen Arm n=6 Participants Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision. Acetaminophen: Infants will receive 15 mg/kg of acetaminophen.	Non-treatment Arm n=5 Participants Routine circumcision without acetaminophen.
Pulse Oximetry Baseline	98.8 percentage of oxygen saturation Interval 97.0 to 100.0	98.2 percentage of oxygen saturation Interval 96.0 to 100.0
Pulse Oximetry 4 Hours post-circumcision	97.5 percentage of oxygen saturation Interval 96.0 to 100.0	98.4 percentage of oxygen saturation Interval 95.0 to 100.0

Adverse Events

Acetaminophen Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-treatment Arm

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

Jennifer Woo Baidal

Columbia University

Phone: 212-342-2962

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Treatment Arm n=6 Participants Includes subjects who received acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision.	Control Arm n=5 Participants Includes subjects who received routine care post circumcision.	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants