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Analgesic Effects of Intravenous Paracetamol on Labor Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01394731
First Posted: July 14, 2011
Last Update Posted: July 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
King Abdulaziz Medical City
Information provided by:
King Abdulaziz University
  Purpose
The purpose of this study is to determine whether intravenous paracetamol is effective in treating labor pain.

Condition Intervention Phase
Labor Pain Drug: Acetaminophen Drug: Meperidine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesic Effects of Intravenous Acetaminophen on Labor Pain

Resource links provided by NLM:


Further study details as provided by King Abdulaziz University:

Primary Outcome Measures:
  • Visual analogue scale (VAS) score for pain [ Time Frame: Up to 24 hours ]
    Patients who give written informed consent to participate will be entered into the study. Their VAS score will be determined every hour from the time of randomization until delivery of the baby. This time will vary from one patient to another depending on the duration of labor.


Study Start Date: December 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paracetamol 1 Drug: Acetaminophen
Experimental: Paraceatmol 2 Drug: Acetaminophen
Active Comparator: Meperidine Drug: Meperidine

  Eligibility

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:

  • American Society of Anesthesiologists physical class I-II
  • term patients (≥ 37 weeks of gestation)

Exclusion Criteria:

  • previous cesarean section
  • hypertension, pre-eclampsia, eclampsia
  • intra-uterine growth retardation
  • intrauterine fetal death
  • morbid obesity (body mass index ≥ 35)
  • allergy to any of the study drugs
  Contacts and Locations
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): NCT01394731


Locations
Saudi Arabia
King Abdulaziz Medical City
Riyadh, Central, Saudi Arabia, 11426
Sponsors and Collaborators
King Abdulaziz University
King Abdulaziz Medical City
  More Information

Responsible Party: Prof. Jamal A. Alhashemi, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT01394731     History of Changes
Other Study ID Numbers: RC08-052
First Submitted: July 12, 2011
First Posted: July 14, 2011
Last Update Posted: July 14, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
Analgesics
Meperidine
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Adjuvants, Anesthesia