Analgesic Effects of Intravenous Paracetamol on Labor Pain

This study has been completed.
Sponsor:
Collaborator:
King Abdulaziz Medical City
Information provided by:
King Abdulaziz University
ClinicalTrials.gov Identifier:
NCT01394731
First received: July 12, 2011
Last updated: July 13, 2011
Last verified: July 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 60 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Prof. Jamal A. Alhashemi, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT01394731     History of Changes
Other Study ID Numbers: RC08-052
Study First Received: July 12, 2011
Last Updated: July 13, 2011
Health Authority: Saudi Arabia: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 20, 2014