Efficacy of Acetaminophen Alone Versus Combination of Acetaminophen/Ibuprofen After Cesarean Section

NCT ID: NCT06479122

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-09

Study Completion Date

2026-08-25

Brief Summary

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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.

Detailed Description

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Conditions

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Cesarean Section Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Acetaminophen

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

1g acetaminophen is administered during skin closure (end of operation).

Acetaminophen

Intervention Type DRUG

1g acetaminophen is administered 6 hours after the first administration.

Acetaminophen/Ibuprofen

Group Type EXPERIMENTAL

Acetaminophen/Ibuprofen

Intervention Type DRUG

A mixture of 1g acetaminophen and 300 mg ibuprofen (Maxigesic®IV) is administered during skin closure (end of operation)

Acetaminophen/Ibuprofen

Intervention Type DRUG

A mixture of 1g acetaminophen and 300 mg ibuprofen (Maxigesic®IV) is administered 6 hours after the first administration.

Interventions

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Acetaminophen

1g acetaminophen is administered during skin closure (end of operation).

Intervention Type DRUG

Acetaminophen/Ibuprofen

A mixture of 1g acetaminophen and 300 mg ibuprofen (Maxigesic®IV) is administered during skin closure (end of operation)

Intervention Type DRUG

Acetaminophen

1g acetaminophen is administered 6 hours after the first administration.

Intervention Type DRUG

Acetaminophen/Ibuprofen

A mixture of 1g acetaminophen and 300 mg ibuprofen (Maxigesic®IV) is administered 6 hours after the first administration.

Intervention Type DRUG

Other Intervention Names

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Acetaminophen #1 Acetaminophen/Ibuprofen #1 Acetaminophen #2 Acetaminophen/Ibuprofen #2

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for elective cesarean section
* Gestational age \> 37+0 weeks

Exclusion Criteria

* 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
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong-Hwa Seo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hansol Kim, MD

Role: CONTACT

+82-10-3160-1548

Junghwa Seo, MD, PhD

Role: CONTACT

Other Identifiers

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2405-052-1535

Identifier Type: -

Identifier Source: org_study_id

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