Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

IV Acetaminophen vs IV Morphine for Pain Control in Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02267772
Recruitment Status : Terminated (Difficulties in recruitment)
First Posted : October 17, 2014
Results First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Jerrie Refuerzo, The University of Texas Health Science Center, Houston

Brief Summary:

Purpose: To determine if IV acetaminophen can 1) decrease pain in pregnancy women, 2)reduce the amount of opioid use in pregnant women who encounter pain, 3) reduce maternal and fetal adverse effects compared to opioids.

Design: This is a comparative effective trial that is a randomized, controlled trial of IV acetaminophen vs. IV morphine in pregnant women.

Procedures: Women meeting inclusion/exclusion criteria will be randomized to IV acetaminophen or IV morphine. The IV acetaminophen group will get up to four standard doses of IV acetaminophen during their stay at the hospital. The second group will get up to six standard doses of morphine. Subjects will complete a pain scale after medication administration and will be asked about any side effects.


Condition or disease Intervention/treatment Phase
Pain Management in Pregnant Women Drug: IV Acetaminophen Drug: IV Morphine Not Applicable

Detailed Description:

Rationale for this clinical trial The goal of analgesia in pregnancy is to reduce pain while minimizing both maternal and fetal adverse effects. Current opioids used in pregnancy provide minimal pain relief and are associated with adverse effects. IV acetaminophen has been shown to significantly improve pain control following cesarean section and in the first stage of labor. Moreover, IV acetaminophen reduces the need and consumption of opioids following surgery. If IV acetaminophen can be as effective in controlling pain associated with maternal medical conditions and uterine contractions with labor, then the use of parenteral opioids in pregnant women and its exposure to the fetus could be reduced. This could provide new opportunities in the medical management of pain in pregnancy. Thus we propose a comparative effectiveness trial of IV acetaminophen compared to IV morphine.

Hypothesis:

We hypothesize that IV acetaminophen is as effective as IV morphine in reducing pain in pregnant women. In doing so, IV acetaminophen can reduce the amount of narcotics needed in women with pain.

Objectives:

To determine if IV acetaminophen can:

  1. Decrease pain in pregnant women
  2. Reduce the amount of opioid use in pregnant women who encounter pain
  3. Reduce maternal and fetal adverse effects compared to opioids

Study Design:

For this comparative effective trial, we propose a randomized, controlled trial of IV acetaminophen vs. IV morphine in pregnant women. Prior studies have confirmed that IV acetaminophen is effective in controlling pain compared to placebo.[14,20] Thus, administering just a placebo for pain control is not justified at this time.

We will include 3 different groups of pregnant populations who encounter pain for different reasons.

Group 1: Pregnant women with uterine contractions, but not in labor Group 2: Pregnant women with uterine contractions in the first stage of labor Group 3: Pregnant women with a medical condition associated with pain.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized, Controlled Trial of IV Acetaminophen Versus IV Morphine to Manage Pain in Pregnancy: Can Opioid Use be Reduced in Pregnant Women?
Study Start Date : January 2014
Actual Primary Completion Date : April 27, 2019
Actual Study Completion Date : April 27, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IV Acetaminophen
IV acetaminophen for pain control
Drug: IV Acetaminophen
IV Acetaminophen

Active Comparator: IV morphine
IV morphine for pain control
Drug: IV Morphine
IV Morphine




Primary Outcome Measures :
  1. Change in Pain Intensity as Assessed by a Visual Analogue Scale (VAS) [ Time Frame: baseline, 120 minutes after administration ]
    The visual analogue scale (VAS) ranges from 0mm to 140mm. The subject will be asked to mark with a pen on the scale to rate their pain. Negative differences in scores indicated a pain score worse than baseline and positive differences indicated an improved pain score from baseline.


Secondary Outcome Measures :
  1. Pain Relief Based on a 5 Point Verbal Scale [ Time Frame: 24 hrs ]
  2. Number of Participants Who Received Rescue Medications [ Time Frame: 24 hours after administration ]
  3. Quantity of Rescue Medication Over 24 Hours [ Time Frame: 24 hours after administration ]
  4. Total Amount of Study Drug Administered [ Time Frame: 24 hours after administration ]
  5. Patient's Global Satisfaction at 24 Hours [ Time Frame: 24hrs ]
    This will be patient reported.

  6. Number of Participants With Maternal Side Effects [ Time Frame: 1 hour after administration ]
    Maternal side effects include nausea, vomiting, headache, pruritus, insomnia, and drowsiness.

  7. Number of Participants With Fetal Heart Rate Changes [ Time Frame: 1 hour after administration ]
    Changes in fetal heart rate tracing include acceleration, decelerations, and variability.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Group 1. We will include pregnant women greater than 24 weeks of pregnancy who present with uterine contractions, but are not in labor and who are warranting treatment with intravenous medication for pain control as part of their routine treatment. This will be defined as the presence of uterine contractions documented on the tocodynamometer. However, the cervix remains less than 2 cm dilated and has not changed after 1 hour after re-examining her cervix.[23]

Group 2. We will include pregnant women greater than 34 weeks of pregnancy who present with uterine contractions and are in the first stage of labor and who are warranting treatment with intravenous medication for pain control as part of their routine treatment. This will be defined as the presence of uterine contractions documented on the tocodynamometer and cervical dilation greater than 2 cm, but less than 6 cm. [23]

Group 3. We will include pregnant women greater than 16 weeks of pregnancy who present with pain due to a maternal medical condition including sickle cell crisis, pyelonephritis, pancreatitis, cholecystitis, nephrolithiasis or headache and who are warranting treatment with intravenous medication for pain control as part of their routine treatment.

Exclusion criteria:

We will exclude women less than 18 years of age, less than 16 weeks gestation, with weight less than 50 kg, and contraindications to acetaminophen including reported elevated liver function tests, hepatic injury, hepatic disorder, active liver disease, alcoholism, chronic malnutrition, known coagulopathy, hemorrhage, creatinine > 1.0, or known allergy or hypersensitivity to acetaminophen. We will also exclude women who have received any opioids within the last 24 hours.


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): NCT02267772


Locations
Layout table for location information
United States, Texas
Lyndon B Johnson Hospital
Houston, Texas, United States, 77026
Memorial Hermann Hospital, Texas Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Layout table for investigator information
Principal Investigator: Jerrie S Refuerzo, MD The University of Texas Health Science Center, Houston
  Study Documents (Full-Text)

Documents provided by Jerrie Refuerzo, The University of Texas Health Science Center, Houston:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jerrie Refuerzo, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02267772    
Other Study ID Numbers: HSC-MS-13-0763
First Posted: October 17, 2014    Key Record Dates
Results First Posted: January 22, 2021
Last Update Posted: January 22, 2021
Last Verified: December 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Acetaminophen
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics