Analgesic Effects of Intravenous Paracetamol on Labor Pain
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The purpose of this study is to determine whether intravenous paracetamol is effective in treating labor pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 12, 2011
CompletedFirst Posted
Study publicly available on registry
July 14, 2011
CompletedJuly 14, 2011
July 1, 2011
7 months
July 12, 2011
July 13, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Up to 24 hours
Study Arms (3)
Paracetamol 1
EXPERIMENTALParaceatmol 2
EXPERIMENTALMeperidine
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists physical class I-II
- term patients (≥ 37 weeks of gestation)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- King Abdulaziz Universitylead
- King Abdulaziz Medical Citycollaborator
Study Sites (1)
King Abdulaziz Medical City
Riyadh, Central, 11426, Saudi Arabia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 12, 2011
First Posted
July 14, 2011
Study Start
December 1, 2010
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
July 14, 2011
Record last verified: 2011-07