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Trial record 57 of 1889 for:    ACETAMINOPHEN

RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Cesarean Pain Relief

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ClinicalTrials.gov Identifier: NCT02046382
Recruitment Status : Completed
First Posted : January 27, 2014
Results First Posted : January 23, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.

Brief Summary:
This study is being done to evaluate the scheduled use of intravenous (IV) acetaminophen among cesarean section patients. The study hopes to find out if patients who receive scheduled IV acetaminophen for 48 hours following delivery have lower self-reported pain scores and use less narcotic pain medication than patients who do not receive IV acetaminophen.

Condition or disease Intervention/treatment Phase
Cesarean Section Pain, Postoperative Drug: IV Acetaminophen Drug: Placebo Phase 4

Detailed Description:
See Brief Summary

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Randomized Control Trial of IV Acetaminophen for Post Cesarean Delivery Pain Relief
Study Start Date : January 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: IV Acetaminophen
Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
Drug: IV Acetaminophen
1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
Other Name: Ofirmev

Placebo Comparator: Normal Saline
Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
Drug: Placebo
100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
Other Name: Normal Saline




Primary Outcome Measures :
  1. Total Oxycodone (mg) [ Time Frame: approximately 2 - 7 days ]
    Total oxycodone (mg) for breakthrough pain during inpatient stay


Secondary Outcome Measures :
  1. Number of Participants With Narcotic Associated Side Effects [ Time Frame: 2-7 days ]
    Only outcome for nausea/emesis is reported.

  2. Length of Stay [ Time Frame: 2-7 days ]
    Length of hospital stay (admission to discharge) will be collected.


Other Outcome Measures:
  1. Total Amount of Ibuprofen During Inpatient Stay [ Time Frame: 2-7 days ]
    Patients will have access to ibuprofen for mild to moderate pain. The amount consumed during inpatient stay will be collected.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Scheduled cesarean section delivery
  • Patient of TriHealth's Faculty Medical Center or Tri-State Maternal Fetal Medicine Associates
  • Singleton pregnancy
  • Term delivery (greater than or equal to 37 weeks)
  • Spinal/epidural anesthesia with epidural analgesia (duramorph)
  • Use of pfannenstiel incision

Exclusion Criteria:

  • Weight less than 50 kg
  • Allergy to study drugs (acetaminophen, oxycodone, duramorph, NSAIDS)
  • Multiple gestation pregnancy
  • Cesarean section for pre-term delivery (less than 37 weeks)
  • Fetal anomalies
  • Inability to use epidural duramorph at time of procedure
  • General anesthesia used
  • Vertical skin incision
  • Opioid addiction
  • Liver dysfunction (hepatitis, HELLP (hemolysis, elevated liver enzymes, and low platelet count), preeclampsia)

Information from the National Library of Medicine

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): NCT02046382


Locations
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United States, Ohio
TriHealth Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
TriHealth Inc.
Investigators
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Principal Investigator: Donna Lambers, MD TriHealth Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT02046382     History of Changes
Other Study ID Numbers: 13068
First Posted: January 27, 2014    Key Record Dates
Results First Posted: January 23, 2018
Last Update Posted: August 16, 2018
Last Verified: February 2018
Keywords provided by TriHealth Inc.:
IV Acetaminophen
Cesarean Section
Pain, Postoperative
Additional relevant MeSH terms:
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Acetaminophen
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics