- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01394731
Analgesic Effects of Intravenous Paracetamol on Labor Pain
July 13, 2011 updated by: King Abdulaziz University
Analgesic Effects of Intravenous Acetaminophen on Labor Pain
The purpose of this study is to determine whether intravenous paracetamol is effective in treating labor pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Central
-
Riyadh, Central, Saudi Arabia, 11426
- King Abdulaziz Medical City
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Meperidine
|
|
Experimental: Paracetamol 1
|
|
Experimental: Paraceatmol 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
July 12, 2011
First Submitted That Met QC Criteria
July 13, 2011
First Posted (Estimate)
July 14, 2011
Study Record Updates
Last Update Posted (Estimate)
July 14, 2011
Last Update Submitted That Met QC Criteria
July 13, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC08-052
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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