Efficacy of Acetaminophen Alone Versus Combination of Acetaminophen/Ibuprofen After Cesarean Section
Efficacy of Intravenous Acetaminophen Alone Versus Combination of Acetaminophen/Ibuprofen (Maxigesic®IV) in Multimodal Analgesia After Cesarean Section: a Randomized Controlled Trial
1 other identifier
interventional
84
1 country
1
Brief Summary
The investigators aim to compare the analgesic efficacy of intravenous acetaminophen alone versus combination of acetaminophen/ibuprofen (Maxigesic®IV) in multimodal analgesia after cesarean section.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2024
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
First Submitted
Initial submission to the registry
June 18, 2024
CompletedFirst Posted
Study publicly available on registry
June 28, 2024
CompletedStudy Start
First participant enrolled
October 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 25, 2026
June 4, 2025
June 1, 2025
1.7 years
June 18, 2024
June 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Obstetric QoR-11K score 24 hours after end of surgery
Minimum 0, poor recovery; maximum 110, good recovery
24 hours after end of surgery
Secondary Outcomes (15)
Numeric rating scale pain score (0-10) 4 hours after end of surgery
4 hours after end of surgery
Numeric rating scale pain score (0-10) 8 hours after end of surgery
8 hours after end of surgery
Numeric rating scale pain score (0-10) 12 hours after end of surgery
12 hours after end of surgery
Numeric rating scale pain score (0-10) 24 h after end of surgery
24 h after end of surgery
Numeric rating scale pain score (0-10) 48 hours after end of surgery
48 hours after end of surgery
- +10 more secondary outcomes
Study Arms (2)
Acetaminophen
ACTIVE COMPARATORAcetaminophen/Ibuprofen
EXPERIMENTALInterventions
1g acetaminophen is administered during skin closure (end of operation).
A mixture of 1g acetaminophen and 300 mg ibuprofen (Maxigesic®IV) is administered during skin closure (end of operation)
Eligibility Criteria
You may qualify if:
- Patients scheduled for elective cesarean section
- Gestational age \> 37+0 weeks
You may not qualify if:
- Emergency cesarean section
- Multiple pregnancy (e.g. twins, triplets)
- Body weight \< 50 kg
- Preeclampsia
- History of hypersensitivity to acetaminophen or ibuprofen
- History of upper gastrointestinal tract bleeding or gastric ulcer
- Underlying liver disease
- Underlying kidney disease or GFR \< 90 mL/min/1.73m2
- Heart failure or severe hypertension
- History of asthma
- Chronic use of barbital or tricyclic antidepressants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Junghwa Seo, MD, PhD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 18, 2024
First Posted
June 28, 2024
Study Start
October 9, 2024
Primary Completion (Estimated)
June 25, 2026
Study Completion (Estimated)
August 25, 2026
Last Updated
June 4, 2025
Record last verified: 2025-06