Trial Outcomes & Findings for Acetaminophen and Post Circumcision Pain Control (NCT NCT02498483)
NCT ID: 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.
TERMINATED
PHASE4
11 participants
Baseline and 4 hours
2019-06-18
Participant Flow
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
| 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=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 hoursThe 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.
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 hoursOutcome 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 hoursPopulation: 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
| 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 hoursOutcome 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
Baseline
|
59.7 breaths per minute
Interval 40.0 to 94.0
|
45 breaths per minute
Interval 40.0 to 52.0
|
|
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
|
SECONDARY outcome
Timeframe: Baseline 4 hoursOutcome 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
Non-treatment Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place