Trial Outcomes & Findings for IV Acetaminophen for Acute Post Operative Pain in C-Section Patients (NCT NCT02069184)

NCT ID: NCT02069184

Last Updated: 2019-08-22

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 66 participants
• Primary outcome timeframe: 24 and 48 hours after Cesarean Section
• Results posted on: 2019-08-22

Participant Flow

Participant milestones

Measure	IV Acetaminophen IV form, total of 4 doses (each 1000 mg), each every 6th hourly to a maximum dose of 4000 mg in 24 hours. IV Acetaminophen: 1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly	Saline as Placebo IV form, total 4 units, each given every 6th hourly in 24 hours. Saline as placebo: 100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly.
Overall Study STARTED	33	33
Overall Study COMPLETED	27	31
Overall Study NOT COMPLETED	6	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

IV Acetaminophen for Acute Post Operative Pain in C-Section Patients

Baseline characteristics by cohort

Measure	IV Acetaminophen n=33 Participants IV form, total of 4 doses (each 1000 mg), each every 6th hourly to a maximum dose of 4000 mg in 24 hours. IV Acetaminophen: 1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly	Saline as Placebo n=33 Participants IV form, total 4 units, each given every 6th hourly in 24 hours. Saline as placebo: 100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly.	Total n=66 Participants Total of all reporting groups
Age, Continuous	31 Years STANDARD_DEVIATION 6 • n=5 Participants	31 Years STANDARD_DEVIATION 5 • n=7 Participants	31 Years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	33 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	33 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 and 48 hours after Cesarean Section

Outcome measures

Measure	IV Acetaminophen n=33 Participants IV form, total of 4 doses (each 1000 mg), each every 6th hourly to a maximum dose of 4000 mg in 24 hours. IV Acetaminophen: 1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly	Saline as Placebo n=33 Participants IV form, total 4 units, each given every 6th hourly in 24 hours. Saline as placebo: 100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly.
Opioid Requirements in Cesarean Section (C-section) Patient Population 24 hours cumulative	44 mg Standard Deviation 23	48 mg Standard Deviation 28
Opioid Requirements in Cesarean Section (C-section) Patient Population 48 hours cumulative	58 mg Standard Deviation 20	57 mg Standard Deviation 22

SECONDARY outcome

Timeframe: every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or up to 48 hours

Post-operative pain was assessed using VAS pain scores (0-10 scale) with 10 being the worst

Outcome measures

Measure	IV Acetaminophen n=33 Participants IV form, total of 4 doses (each 1000 mg), each every 6th hourly to a maximum dose of 4000 mg in 24 hours. IV Acetaminophen: 1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly	Saline as Placebo n=33 Participants IV form, total 4 units, each given every 6th hourly in 24 hours. Saline as placebo: 100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly.
Visual Analog Score (VAS) Pain Score 6 hours after CS pain	3.4 scores on a scale Standard Deviation 2.6	3.6 scores on a scale Standard Deviation 2.5
Visual Analog Score (VAS) Pain Score 12 hours after CS	1.2 scores on a scale Standard Deviation 1.9	2.3 scores on a scale Standard Deviation 2.7
Visual Analog Score (VAS) Pain Score 18 hours after CS	3.1 scores on a scale Standard Deviation 2.7	2.9 scores on a scale Standard Deviation 3.0
Visual Analog Score (VAS) Pain Score 32 hours after CS	3.1 scores on a scale Standard Deviation 2.4	2.9 scores on a scale Standard Deviation 2.3
Visual Analog Score (VAS) Pain Score 0 hr pain after CS	2.2 scores on a scale Standard Deviation 2.9	1.4 scores on a scale Standard Deviation 2
Visual Analog Score (VAS) Pain Score 24 hours after CS	4.0 scores on a scale Standard Deviation 3.2	5.1 scores on a scale Standard Deviation 2.1
Visual Analog Score (VAS) Pain Score 40 hours after CS	2.0 scores on a scale Standard Deviation 2.2	1.2 scores on a scale Standard Deviation 1.8
Visual Analog Score (VAS) Pain Score 48 hours after CS	3.2 scores on a scale Standard Deviation 2.5	2.6 scores on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: Percentage of Participants Reporting to be Wide Awake up to 72 hours after the C-section

Sedation was assessed on a scale of 1-3 (1= wide awake, 2= sleepy but easily aroused, 3= sleepy and difficult to arouse). These assessments were made at the same time points as the pain assessments by the same research assistant. Score 1 is the only good outcome.

Outcome measures

Measure	IV Acetaminophen n=27 Participants IV form, total of 4 doses (each 1000 mg), each every 6th hourly to a maximum dose of 4000 mg in 24 hours. IV Acetaminophen: 1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly	Saline as Placebo n=31 Participants IV form, total 4 units, each given every 6th hourly in 24 hours. Saline as placebo: 100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly.
Percentage of Participants Reporting to be Wide Awake up to 72 Hours After the C-section	95 percentage of patients	95 percentage of patients

SECONDARY outcome

Timeframe: every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or upto 72 hours. Finally, 1 week after discharge.

Subjects were specifically asked about adverse events such as nausea, vomiting, pruritus and breathing difficulties and information regarding their bowel movements. This information was collected on a scale of none, mild, moderate or severe. These are categorical outcomes.

Outcome measures

Measure	IV Acetaminophen n=33 Participants IV form, total of 4 doses (each 1000 mg), each every 6th hourly to a maximum dose of 4000 mg in 24 hours. IV Acetaminophen: 1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly	Saline as Placebo n=33 Participants IV form, total 4 units, each given every 6th hourly in 24 hours. Saline as placebo: 100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly.
"Percentage of Patients With Adverse Events After the Surgery 24 hour nausea	22 percentage of patients	27 percentage of patients
"Percentage of Patients With Adverse Events After the Surgery 24 hour vomiting	21 percentage of patients	27 percentage of patients
"Percentage of Patients With Adverse Events After the Surgery 24 hour itching	57 percentage of patients	63 percentage of patients
"Percentage of Patients With Adverse Events After the Surgery 24 hour breathing difficulty	9 percentage of patients	6 percentage of patients

SECONDARY outcome

Timeframe: every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or upto 72 hours.

Population: None of the participants used PCA pumps so no data could be collected for this outcome measure. PCA was not part of the standard of care at our hospital.

Data were not collected.The use of patient-controlled analgesia (PCA) pumps could have been utilized to standardize rescue medications. This would have allowed the collection of the proportion of subjects that required additional rescue medications. This was another possible endpoint that could have been evaluated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From time of discharge to 1 week after discharge

No patients were re hospitalized in the first 7 days

Outcome measures

Measure	IV Acetaminophen n=33 Participants IV form, total of 4 doses (each 1000 mg), each every 6th hourly to a maximum dose of 4000 mg in 24 hours. IV Acetaminophen: 1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly	Saline as Placebo n=33 Participants IV form, total 4 units, each given every 6th hourly in 24 hours. Saline as placebo: 100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly.
Percentage of Participants That Were Re-Hospitalized 1 Week After Discharge	0 percentage of patients	0 percentage of patients

SECONDARY outcome

Timeframe: For the first 24 hours after the c-section until the patient is discharged or up to 48 hours

Compare the percentage of patients using non-opioid pain medication at 24 hours, and 48 hours and had experienced any adverse events.

Outcome measures

Measure	IV Acetaminophen n=33 Participants IV form, total of 4 doses (each 1000 mg), each every 6th hourly to a maximum dose of 4000 mg in 24 hours. IV Acetaminophen: 1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly	Saline as Placebo n=33 Participants IV form, total 4 units, each given every 6th hourly in 24 hours. Saline as placebo: 100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly.
Pain Medication Usage ( NSAIDS)	27 percentage of patients	30.3 percentage of patients

Adverse Events

IV Acetaminophen

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Saline as Placebo

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	IV Acetaminophen n=33 participants at risk IV form, total of 4 doses (each 1000 mg), each every 6th hourly to a maximum dose of 4000 mg in 24 hours. IV Acetaminophen: 1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly	Saline as Placebo n=33 participants at risk IV form, total 4 units, each given every 6th hourly in 24 hours. Saline as placebo: 100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly.
Gastrointestinal disorders Nausea	21.2% 7/33 • Number of events 7 • 24 hours, 48 hours and up to one week after surgery Serious and Other (Not Including Serious) Adverse Events	21.2% 7/33 • Number of events 7 • 24 hours, 48 hours and up to one week after surgery Serious and Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Vomiting	12.1% 4/33 • Number of events 4 • 24 hours, 48 hours and up to one week after surgery Serious and Other (Not Including Serious) Adverse Events	3.0% 1/33 • Number of events 1 • 24 hours, 48 hours and up to one week after surgery Serious and Other (Not Including Serious) Adverse Events
Infections and infestations Pruritis	48.5% 16/33 • Number of events 16 • 24 hours, 48 hours and up to one week after surgery Serious and Other (Not Including Serious) Adverse Events	45.5% 15/33 • Number of events 15 • 24 hours, 48 hours and up to one week after surgery Serious and Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Breathing Difficulty	9.1% 3/33 • Number of events 3 • 24 hours, 48 hours and up to one week after surgery Serious and Other (Not Including Serious) Adverse Events	3.0% 1/33 • Number of events 1 • 24 hours, 48 hours and up to one week after surgery Serious and Other (Not Including Serious) Adverse Events

Additional Information

Jeffrey Bernstein

Montefiore Medical Center

Phone: 718-920-4317

Email: JBernste@montefiore.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place