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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
Sponsor:
Information provided by (Responsible Party):
Jerrie Refuerzo, The University of Texas Health Science Center, Houston

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.


Condition or disease Intervention/treatment Phase
Pain Management in Pregnant Women Drug: IV Acetaminophen Drug: IV Morphine Not Applicable

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 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.

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IV Acetaminophen
IV acetaminophen for pain control
Drug: IV Acetaminophen
IV Acetaminophen

Active Comparator: IV morphine
IV morphine for pain control
Drug: IV Morphine
IV Morphine




Primary Outcome Measures :
  1. 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:

    1. prior to administration of the medication
    2. 15 minutes after administration
    3. 1 hours after administration
    4. 2 hours after administration
    5. 6 hours after administration. This will be obtained within 30 minutes after the second dose is given.
    6. 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.



Secondary Outcome Measures :
  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

  2. The time to first rescue medication [ Time Frame: 24 hrs ]
    The time to first rescue medication

  3. 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. 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. 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. 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. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 tocodynanometer. 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 tocodynanometer 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 coagulapathy, 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.


Information from the National Library of Medicine

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


Contacts
Contact: Jerrie S Refuerzo, MD 713.500.6416 Jerrie.s.refuerzo@uth.tmc.edu
Contact: Maria Hutchinson, MS 713.500.5850 maria.s.keefer@uth.tmc.edu

Locations
United States, Texas
Lyndon B Johnson Hospital Recruiting
Houston, Texas, United States, 77026
Contact: Jerrie S Refuerzo, MD    713-500-6416    jerrie.s.refuerzo@uth.tmc.edu   
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   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Jerrie S Refuerzo, MD The University of Texas Health Science Center, Houston

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jerrie Refuerzo, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02267772     History of Changes
Other Study ID Numbers: HSC-MS-13-0763
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
Morphine
Acetaminophen
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics