IV Acetaminophen vs IV Morphine for Pain Control in Pregnant Women
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|ClinicalTrials.gov Identifier: NCT02267772|
Recruitment Status : Recruiting
First Posted : October 17, 2014
Last Update Posted : November 2, 2018
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 opiods 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)|
|Estimated Enrollment :||330 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|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||May 2020|
Experimental: IV Acetaminophen
IV acetaminophen for pain control
Drug: IV Acetaminophen
Active Comparator: IV morphine
IV morphine for pain control
Drug: IV Morphine
- Pain intensity [ Time Frame: 24 hours after administration ]
The primary outcome variable will be the summed difference in pain intensity in those women in Group 2 in the first stage of labor. Pain intensity will be based on a 100 mm visual analog scale. The subject will be asked to mark with a pen on the scale to rate their pain. If they are unable to mark the scale with a pen, this will be noted.
The pain intensity via the VAS will determined at 6 time points:
- prior to administration of the medication
- 15 minutes after administration
- 1 hours after administration
- 2 hours after administration
- 6 hours after administration. This will be obtained within 30 minutes after the second dose is given.
- 24 hours after administration if the patient is still hospitalized. This will be obtained within 30 minutes after 24 hour dose is given.
The summed difference in pain intensity will be defined as the difference in pain scale from each point 2-6 minus point 1.
- Pain relief based on a 5 point verbal scale at 15 minutes, 1, 2, 6 and 24 hours [ Time Frame: 24 hrs ]Pain relief based on a 5 point verbal scale at 15 minutes, 1, 2, 6 and 24 hours
- The time to first rescue medication [ Time Frame: 24 hrs ]The time to first rescue medication
- 3. The quantity of rescue medication over 24 hours or hospital stay [ Time Frame: 24hrs or hospital stay ]3. The quantity of rescue medication over 24 hours or hospital stay
- 4. Total amount of either acetaminophen, morphine or other analgesics over 24 hours [ Time Frame: 24hrs ]4. Total amount of either acetaminophen, morphine or other analgesics over 24 hours
- 5. Patient's global satisfaction at 24 hours. This will be patient reported. [ Time Frame: 24hrs ]5. Patient's global satisfaction at 24 hours. This will be patient reported.
- 6. Reports of maternal adverse effects such as nausea, vomiting, pruritus, headache, pyrexia, insomnia, sedation [ Time Frame: 24hrs or hospital stay ]6. Reports of maternal adverse effects such as nausea, vomiting, pruritus, headache, pyrexia, insomnia, sedation
- 7. Effects on fetal heart rate tracing including acceleration, decelerations, change in baseline and variability. This will occur about 30 minutes after the medication is given with a range of ± 30 minutes. [ Time Frame: 24hrs ]7. Effects on fetal heart rate tracing including acceleration, decelerations, change in baseline and variability. This will occur about 30 minutes after the medication is given with a range of ± 30 minutes.
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
|Contact: Jerrie S Refuerzo, MD||713.500.6416||Jerrie.firstname.lastname@example.org|
|Contact: Maria Hutchinson, MSemail@example.com|
|United States, Texas|
|Lyndon B Johnson Hospital||Recruiting|
|Houston, Texas, United States, 77026|
|Contact: Jerrie S Refuerzo, MD 713-500-6416 firstname.lastname@example.org|
|Memorial Hermann Hospital, Texas Medical Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Jerrie S Refuerzo, MD 713-500-6416 Jerrie.S.Refuerzo@uth.tmc.edu|
|Principal Investigator:||Jerrie S Refuerzo, MD||The University of Texas Health Science Center, Houston|