An interventional study of IV Acetaminophen and IV Morphine in Pain Management in Pregnant Women, sponsored by The University of Texas Health Science Center, Houston. Terminated at 2 sites in United States. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-01-22.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Other
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.
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:
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.
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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.
IV acetaminophen for pain control
Drug: IV Acetaminophen
IV morphine for pain control
Drug: IV Morphine
IV Acetaminophen
IV Morphine
Change in Pain Intensity as Assessed by a Visual Analogue Scale (VAS)
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.
Time frame: baseline, 120 minutes after administration
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
This will be patient reported.
Time frame: 24hrs
Number of Participants With Maternal Side Effects
Maternal side effects include nausea, vomiting, headache, pruritus, insomnia, and drowsiness.
Time frame: 1 hour after administration
Number of Participants With Fetal Heart Rate Changes
Changes in fetal heart rate tracing include acceleration, decelerations, and variability.
Time frame: 1 hour after administration
| Milestone | IV Acetaminophen | IV Morphine |
|---|---|---|
| Started | 50 | 52 |
| Randomized | 50 | 52 |
| Received study drug | 48 | 52 |
| Completed | 48 | 52 |
| Not completed | 2 | 0 |
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.
| score on a scale | IV Acetaminophen | IV Morphine |
|---|---|---|
| pre-labor group | 2.67 ± 3.8 | 3.2 ± 5.1 |
| first stage of labor group | -18.2 ± 13.2 | -4.8 ± 12.5 |
No measurements were reported for this outcome.
| Participants | IV Acetaminophen | IV Morphine |
|---|---|---|
| Number of Participants Who Received Rescue Medications | 30 | 19 |
No measurements were reported for this outcome.
| milligrams | IV Acetaminophen | IV Morphine |
|---|---|---|
| pre-labor group | 1600 ± 952.2 | 6.4 ± 1.9 |
| 1st stage of labor group | 1055 ± 229 | 2.3 ± 0.72 |
This will be patient reported.
No measurements were reported for this outcome.
Maternal side effects include nausea, vomiting, headache, pruritus, insomnia, and drowsiness.
| Participants | IV Acetaminophen | IV Morphine |
|---|---|---|
| nausea | 2 | 2 |
| vomiting | 0 | 3 |
| headache | 5 | 6 |
| pruritus | 2 | 4 |
| insomnia | 5 | 7 |
| drowsiness | 17 | 15 |
Changes in fetal heart rate tracing include acceleration, decelerations, and variability.
| Participants | IV Acetaminophen | IV Morphine |
|---|---|---|
| absence of accelerations | 4 | 12 |
| late decelerations | 1 | 1 |
| minimal or absent variability | 4 | 3 |
Collected over 1 hour after administration. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IV Acetaminophen | 0/48 (0%) | 1/48 (2.1%) | 21/43 (48.8%) |
| IV Morphine | 0/52 (0%) | 0/52 (0%) | 15/51 (29.4%) |
| Event | IV Acetaminophen | IV Morphine |
|---|---|---|
| Adverse reaction to demerol administered as rescue medication, which required narcan for reversalGeneral disorders | 1/48 | 0/52 |
| Event | IV Acetaminophen | IV Morphine |
|---|---|---|
| DrowsinessGeneral disorders | 17/43 | 15/51 |
| InsomniaGeneral disorders | 5/43 | 7/51 |
| HeadacheGeneral disorders | 5/43 | 6/51 |
| PruritusSkin and subcutaneous tissue disorders | 2/43 | 4/51 |
| VomitingGastrointestinal disorders | 0/43 | 3/51 |
| NauseaGeneral disorders | 2/43 | 2/51 |
| Age, Continuous(years) | IV Acetaminophen | IV Morphine | Total |
|---|---|---|---|
| Mean | 27.0 ± 5.5 | 27.5 ± 6.0 | 27.3 ± 5.8 |
| Sex: Female, Male(Participants) | IV Acetaminophen | IV Morphine | Total |
|---|---|---|---|
| Female | 48 | 52 | 100 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | IV Acetaminophen | IV Morphine | Total |
|---|---|---|---|
| Asian | 1 | 1 | 2 |
| Black | 19 | 24 | 43 |
| Caucasian | 5 | 8 | 13 |
| Hispanic | 19 | 21 | 40 |
| Other | 2 | 2 | 4 |
| Region of Enrollment(participants) | IV Acetaminophen | IV Morphine | Total |
|---|---|---|---|
| United States | 48 | 52 | 100 |
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The University of Texas Health Science Center, Houston