Status:
TERMINATED
IV Acetaminophen vs IV Morphine for Pain Control in Pregnant Women
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Pain Management in Pregnant Women
Eligibility:
FEMALE
18-60 years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2019
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT02267772
Start Date
January 1 2014
End Date
April 27 2019
Last Update
January 22 2021
Active Locations (2)
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1
Lyndon B Johnson Hospital
Houston, Texas, United States, 77026
2
Memorial Hermann Hospital, Texas Medical Center
Houston, Texas, United States, 77030