Clinical trial NCT02267772: IV Acetaminophen vs IV Morphine for Pain Control in Pregnant Women
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain Management in Pregnant Women
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 163
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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.

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 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:

1. Decrease pain in pregnant women
2. Reduce the amount of opioid use in pregnant women who encounter pain
3. Reduce maternal and fetal adverse effects compared to opioids

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Pain Intensity as Assessed by a Visual Analogue Scale (VAS)
timeFrame: baseline, 120 minutes after administration
Secondary outcomes:
measure: Pain Relief Based on a 5 Point Verbal Scale
timeFrame: 24 hrs
measure: Number of Participants Who Received Rescue Medications
timeFrame: 24 hours after administration
measure: Quantity of Rescue Medication Over 24 Hours
timeFrame: 24 hours after administration
measure: Total Amount of Study Drug Administered
timeFrame: 24 hours after administration
measure: Patient's Global Satisfaction at 24 Hours
timeFrame: 24hrs
measure: Number of Participants With Maternal Side Effects
timeFrame: 1 hour after administration
measure: Number of Participants With Fetal Heart Rate Changes
timeFrame: 1 hour after administration
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon B Johnson Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital, Texas Medical Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jerrie S Refuerzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ankumah NE, Tsao M, Hutchinson M, Pedroza C, Mehta J, Sibai BM, Chauhan SP, Blackwell SC, Refuerzo JS. Intravenous Acetaminophen versus Morphine for Analgesia in Labor: A Randomized Trial. Am J Perinatol. 2017 Jan;34(1):38-43. doi: 10.1055/s-0036-1584143. Epub 2016 May 16.