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Acetaminophen and Post Circumcision Pain Control

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ClinicalTrials.gov Identifier: NCT02498483
Recruitment Status : Terminated (Understaffing)
First Posted : July 15, 2015
Results First Posted : June 11, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Pain
Circumcision
Intervention Drug: Acetaminophen
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Arm Control Arm
Hide Arm/Group Description Includes subjects who received acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision. Includes subjects who received routine care post circumcision.
Period Title: Overall Study
Started 6 5
Completed 6 5
Not Completed 0 0
Arm/Group Title Treatment Arm Control Arm Total
Hide Arm/Group Description Includes subjects who received acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision. Includes subjects who received routine care post circumcision. Total of all reporting groups
Overall Number of Baseline Participants 6 5 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
<=18 years
6
 100.0%
5
 100.0%
11
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
6
 100.0%
5
 100.0%
11
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
Hispanic or Latino
4
  66.7%
3
  60.0%
7
  63.6%
Not Hispanic or Latino
2
  33.3%
2
  40.0%
4
  36.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  33.3%
0
   0.0%
2
  18.2%
White
0
   0.0%
2
  40.0%
2
  18.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
  66.7%
3
  60.0%
7
  63.6%
1.Primary Outcome
Title Neonatal Infant Pain Scale (NIPS)
Hide Description 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.
Time Frame Baseline and 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Arm Non-treatment Arm
Hide Arm/Group Description:

Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision.

Acetaminophen: Infants will receive 15 mg/kg of acetaminophen.

Routine circumcision without acetaminophen.
Overall Number of Participants Analyzed 6 5
Mean (Full Range)
Unit of Measure: score on a scale
Baseline
2.5
(0 to 7)
3.2
(0 to 6)
4 Hours post-circumcision
1.0
(0 to 2)
1.4
(0 to 3)
2.Secondary Outcome
Title Heart Rate
Hide Description [Not Specified]
Time Frame Baseline and 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Arm Non-treatment Arm
Hide Arm/Group Description:

Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision.

Acetaminophen: Infants will receive 15 mg/kg of acetaminophen.

Routine circumcision without acetaminophen.
Overall Number of Participants Analyzed 6 5
Mean (Full Range)
Unit of Measure: Beats per minute
Baseline
138.7
(120 to 156)
128.8
(108 to 179)
4 Hours post-circumcision
125
(116 to 136)
124.8
(101 to 150)
3.Secondary Outcome
Title Change in Salivary Cortisol Rise
Hide Description [Not Specified]
Time Frame Baseline and 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Acetaminophen Arm Non-treatment Arm
Hide Arm/Group Description:

Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision.

Acetaminophen: Infants will receive 15 mg/kg of acetaminophen.

Routine circumcision without acetaminophen.
Overall Number of Participants Analyzed 5 3
Mean (Full Range)
Unit of Measure: nmol/L
Baseline
0.389
(0.159 to 0.917)
0.427
(0.171 to 0.721)
30 minutes post-circumcision
1.085
(0.439 to 2.779)
0.811
(0.702 to 0.925)
4.Secondary Outcome
Title Respiratory Rate
Hide Description [Not Specified]
Time Frame Baseline and 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Arm Non-treatment Arm
Hide Arm/Group Description:

Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision.

Acetaminophen: Infants will receive 15 mg/kg of acetaminophen.

Routine circumcision without acetaminophen.
Overall Number of Participants Analyzed 6 5
Mean (Full Range)
Unit of Measure: breaths per minute
Baseline
59.7
(40 to 94)
45
(40 to 52)
4 Hours post-circumcision
42
(28 to 58)
43.6
(40 to 56)
5.Secondary Outcome
Title Pulse Oximetry
Hide Description [Not Specified]
Time Frame Baseline 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Arm Non-treatment Arm
Hide Arm/Group Description:

Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision.

Acetaminophen: Infants will receive 15 mg/kg of acetaminophen.

Routine circumcision without acetaminophen.
Overall Number of Participants Analyzed 6 5
Mean (Full Range)
Unit of Measure: percentage of oxygen saturation
Baseline
98.8
(97 to 100)
98.2
(96 to 100)
4 Hours post-circumcision
97.5
(96 to 100)
98.4
(95 to 100)
Time Frame [Not Specified]
Adverse Event Reporting Description The AE data is reported for the combination of all arms/groups because the data was collected and observed for the entire study population and not per arm.
 
Arm/Group Title Acetaminophen Arm Non-treatment Arm
Hide Arm/Group Description Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision. Routine circumcision without acetaminophen.
All-Cause Mortality
Acetaminophen Arm Non-treatment Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/5 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Acetaminophen Arm Non-treatment Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Acetaminophen Arm Non-treatment Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/5 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jennifer Woo Baidal
Organization: Columbia University
Phone: 212-342-2962
EMail: jw3286@cumc.columbia.edu
Layout table for additonal information
Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT02498483     History of Changes
Other Study ID Numbers: AAAN7406
First Submitted: June 30, 2015
First Posted: July 15, 2015
Results First Submitted: March 26, 2019
Results First Posted: June 11, 2019
Last Update Posted: June 18, 2019