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Clinical Trials/NCT05907993
NCT05907993CompletedPhase 4

The Effectiveness Of Intravenous Ibuprofen Versus Intravenous Ketorolac For Postoperative Pain Relief After Cesarean Section

Alexandria University1 site in 1 country50 target enrollmentStarted: February 1, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
measurement of visual analogue score

Study Overview

Brief Summary

The aim of this study will be to evaluate the effectiveness of intravenous ibuprofen versus intravenous ketorolac for postoperative pain relief after caesarian section

  1. The Primary outcome is measurement of visual analogue score during rest and movement
  2. The Secondary outcome is measurement of 24 hours opioids requirements.

Detailed Description

METHODS

  1. Preoperative assessment:

All parturients included in the study will be assessed thoroughly by:

  1. Proper history taking

  2. Complete clinical examination.

  3. All needed laboratory investigations.

  4. Patient preparation:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Parturients aged 20-30years.
  • ASA physical satatus: II.
  • Anticipated hospital stay for at least 24 hours.
  • Refusal of spinal anaesthesia.

Exclusion Criteria

  • Known allergy to the used drugs.
  • Renal and hepatic impairement
  • History of brochial asthma.
  • Low platelets count (<70000).
  • Bleeding diathesis and with history or risk of intracranial hemorrhage.
  • Obese and morbidly obese parturients.
  • GIT problems as gastritis or GI bleeding.

Arms & Interventions

Group (B):

Active Comparator

800mg ibuprofen in 200cc normal saline intravenously every 6 hours for 24hours postoperatively.

Intervention: Ibuprofen 800 mg (Drug)

Outcomes

Primary Outcomes

measurement of visual analogue score

Time Frame: after the surgery average 24 hours postoperative

measurement of visual analogue score during rest and movement . The Score range from 0- 10 . 0 means no pain and 10 indicates the worst pain ever

Secondary Outcomes

  • opioids requirements.(after the surgery average 24 hours postoperative)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Shehab, MD

lecturer Of Anaesthesia and Surgical intensive care

Alexandria University

Study Sites (1)

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