IV Acetaminophen vs IV Morphine for Pain Control in Pregnant Women
Stopped early · Not applicable
Conditions studied: Pain Management in Pregnant Women
In brief
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.
Key facts
- Study ID
- NCT02267772
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 163
- Starts
- 2014-01-01
- Expected to finish
- 2019-04-27
- Last updated by the study team
- 2021-01-22
Who can join
Age: 18 and older, up to 60. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Lyndon B Johnson Hospital — Houston, Texas, United States
- Memorial Hermann Hospital, Texas Medical Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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