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

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Seoul National University

Status and phase

Enrolling
Phase 4

Conditions

Postoperative Pain
Cesarean Section

Treatments

Drug: Acetaminophen
Drug: Acetaminophen/Ibuprofen

Study type

Interventional

Funder types

Other

Identifiers

NCT06479122
2405-052-1535

Details and patient eligibility

About

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.

Enrollment

84 estimated patients

Sex

Female

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

84 participants in 2 patient groups

Acetaminophen
Active Comparator group
Treatment:
Drug: Acetaminophen
Drug: Acetaminophen
Acetaminophen/Ibuprofen
Experimental group
Treatment:
Drug: Acetaminophen/Ibuprofen
Drug: Acetaminophen/Ibuprofen

Trial contacts and locations

1

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Central trial contact

Junghwa Seo, MD, PhD; Hansol Kim, MD

Data sourced from clinicaltrials.gov

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