Back to resultsAnalgesic Effects of Intravenous Paracetamol on Labor Pain
Primary Purpose
Labor Pain
Status
Completed
Phase
Phase 4
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Acetaminophen
Meperidine
Sponsored by
About this trial
This is an interventional treatment trial for Labor Pain
Eligibility 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
Sites / Locations
- King Abdulaziz Medical City
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Paracetamol 1
Paraceatmol 2
Meperidine
Arm Description
Outcomes
Primary Outcome Measures
Visual analogue scale (VAS) score for pain
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01394731
First Posted
July 12, 2011
Last Updated
July 13, 2011
Sponsor
King Abdulaziz University
Collaborators
King Abdulaziz Medical City
1. Study Identification
Unique Protocol Identification Number
NCT01394731
Brief Title
Analgesic Effects of Intravenous Paracetamol on Labor Pain
Official Title
Analgesic Effects of Intravenous Acetaminophen on Labor Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
King Abdulaziz University
Collaborators
King Abdulaziz Medical City
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether intravenous paracetamol is effective in treating labor pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
Paracetamol 1
Arm Type
Experimental
Arm Title
Paraceatmol 2
Arm Type
Experimental
Arm Title
Meperidine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Type
Drug
Intervention Name(s)
Meperidine
Primary Outcome Measure Information:
Title
Visual analogue scale (VAS) score for pain
Description
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.
Time Frame
Up to 24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
King Abdulaziz Medical City
City
Riyadh
State/Province
Central
ZIP/Postal Code
11426
Country
Saudi Arabia
12. IPD Sharing Statement
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Analgesic Effects of Intravenous Paracetamol on Labor Pain
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