IV Acetaminophen vs IV Morphine for Pain Control in Pregnant Women

NCT02267772 | Terminated Results

• 1 other identifier: HSC-MS-13-0763
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain Management in Pregnant Women

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 120 minutes after administration

Secondary Outcomes (7)

• Pain Relief Based on a 5 Point Verbal Scale

  24 hrs

• Number of Participants Who Received Rescue Medications

  24 hours after administration

• Quantity of Rescue Medication Over 24 Hours

  24 hours after administration

• Total Amount of Study Drug Administered

  24 hours after administration

• Patient's Global Satisfaction at 24 Hours

  24hrs

Study Arms (2)

IV Acetaminophen

EXPERIMENTAL

IV acetaminophen for pain control

Drug: IV Acetaminophen

IV morphine

ACTIVE COMPARATOR

IV morphine for pain control

Drug: IV Morphine

Interventions

IV Acetaminophen DRUG

IV Acetaminophen

IV Acetaminophen

IV Morphine DRUG

IV Morphine

IV morphine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (2)

Lyndon B Johnson Hospital

Houston, Texas, 77026, United States

Location

Memorial Hermann Hospital, Texas Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 27182992 DERIVED

MeSH Terms

Interventions

Acetaminophen; Morphine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Jerrie S. Refuerzo, MD, Associate Professor
• Organization: The University of Texas Health Science Center at Houston

jerrie.s.refuerzo@uth.tmc.edu

713-500-6416

Study Officials

• Jerrie S Refuerzo, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 17, 2014
• Study Start: January 1, 2014
• Primary Completion: April 27, 2019
• Study Completion: April 27, 2019
• Last Updated: January 22, 2021
• Results First Posted: January 22, 2021

Record last verified: 2020-12

Locations

US (2)