IV Acetaminophen for Acute Post Operative Pain in C-Section Patients
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|ClinicalTrials.gov Identifier: NCT02069184|
Recruitment Status : Completed
First Posted : February 24, 2014
Results First Posted : August 22, 2019
Last Update Posted : August 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Post-operative Pain||Drug: IV Acetaminophen Other: Saline as placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double Blinded Randomized Placebo Controlled Study in Evaluating the Effectiveness of IV Acetaminophen for Acute Post Operative Pain in C-Section Patients|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: 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.
Drug: IV Acetaminophen
1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly
Other Name: IV Tylenol
Experimental: Saline as placebo
IV form, total 4 units, each given every 6th hourly in 24 hours.
Other: 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 [ Time Frame: 24 and 48 hours after Cesarean Section ]
- Visual Analog Score (VAS) Pain Score [ Time Frame: 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
- Percentage of Participants Reporting to be Wide Awake up to 72 Hours After the C-section [ Time Frame: 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.
- "Percentage of Patients With Adverse Events After the Surgery [ Time Frame: 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.
- Number of Participants Using Patient-controlled Analgesia (PCA) Attempts [ Time Frame: 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. ]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.
- Percentage of Participants That Were Re-Hospitalized 1 Week After Discharge [ Time Frame: From time of discharge to 1 week after discharge ]No patients were re hospitalized in the first 7 days
- Pain Medication Usage ( NSAIDS) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069184
|United States, New York|
|Montefiore Medical Center- Weiler|
|Bronx, New York, United States, 10467|
|Principal Investigator:||Jeffrey Bernstein, MD||Montefiore Medical Center|