Ibuprofen Versus Ketorolac For Postoperative Pain Relief After Cesarean Section

NCT05907993 | Completed Phase 4

• 1 other identifier: 0107307
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Pain, Postoperative

Keywords

postoperative; pain relief; CESAREAN SECTION

Outcome Measures

Primary Outcomes (1)

• measurement of visual analogue score

  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

  after the surgery average 24 hours postoperative

Secondary Outcomes (1)

• opioids requirements.

  after the surgery average 24 hours postoperative

Study Arms (2)

Group (A):

NO INTERVENTION

30mg ketorolac in 200cc normal saline intravenously every 6hours for 24hours postoperatively.

Group (B):

ACTIVE COMPARATOR

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

Drug: Ibuprofen 800 mg

Interventions

Ibuprofen 800 mg DRUG

Intravenous Ibuprofen versus intravenous Ketorolac for postoperative pain relief

Group (B):

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnant Females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Ahmed S. Shehab

Alexandria, 21431, Egypt

Location

Related Publications (1)

• Ekinci M, Ciftci B, Celik EC, Kose EA, Karakaya MA, Ozdenkaya Y. A Randomized, Placebo-Controlled, Double-Blind Study that Evaluates Efficacy of Intravenous Ibuprofen and Acetaminophen for Postoperative Pain Treatment Following Laparoscopic Cholecystectomy Surgery. J Gastrointest Surg. 2020 Apr;24(4):780-785. doi: 10.1007/s11605-019-04220-1. Epub 2019 Apr 22.

  PMID: 31012040 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Ahmed S. Shehab, MD

  Alexandria University

  PRINCIPAL INVESTIGATOR

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
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer Of Anaesthesia and Surgical intensive care

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: June 18, 2023
• Study Start: February 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: October 30, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: to the time when summary data are published
• Access Criteria: Accessible through the web site

Locations

EG (1)