IV Acetaminophen vs IV Morphine for Pain Control in Pregnant Women
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|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
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|
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.
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.
To determine if IV acetaminophen can:
- Decrease pain in pregnant women
- Reduce the amount of opioid use in pregnant women who encounter pain
- Reduce maternal and fetal adverse effects compared to opioids
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||163 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: IV Acetaminophen
IV acetaminophen for pain control
Drug: IV Acetaminophen
Active Comparator: IV morphine
IV morphine for pain control
Drug: IV Morphine
- 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.
- Pain Relief Based on a 5 Point Verbal Scale [ Time Frame: 24 hrs ]
- Number of Participants Who Received Rescue Medications [ Time Frame: 24 hours after administration ]
- Quantity of Rescue Medication Over 24 Hours [ Time Frame: 24 hours after administration ]
- Total Amount of Study Drug Administered [ Time Frame: 24 hours after administration ]
- Patient's Global Satisfaction at 24 Hours [ Time Frame: 24hrs ]This will be patient reported.
- Number of Participants With Maternal Side Effects [ Time Frame: 1 hour after administration ]Maternal side effects include nausea, vomiting, headache, pruritus, insomnia, and drowsiness.
- 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.
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
|United States, Texas|
|Lyndon B Johnson Hospital|
|Houston, Texas, United States, 77026|
|Memorial Hermann Hospital, Texas Medical Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jerrie S Refuerzo, MD||The University of Texas Health Science Center, Houston|