Comparison of Two Dosing Regimens of Intravenous Ketorolac for Post-Cesarean Pain Control

NCT ID: NCT07244757

Last Updated: 2026-01-13

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

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-03-31

Brief Summary

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we aim to compare the analgesic efficacy of two intravenous ketorolac dosing regimens as part of a multimodal analgesic protocol that includes local wound infiltration for postoperative pain management after elective cesarean delivery.

Detailed Description

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Spinal anesthesia will be achieved by injecting 10 mg hyperbaric bupivacaine 0.5% plus 25 mcg fentanyl Prophylactic vasopressor will be administered in all patients, Following delivery, all patients will receive a single dose of dexamethasone (8 mg) along with the first dose of intravenous ketorolac. Subsequent ketorolac doses will be administered every 8 hours.

After closing the fascia, the subcutaneous layer will be infiltrated with 30 mL of 0.25% bupivacaine.

Postoperatively, if the Numeric rating scale is \> 3, intravenous nalbuphine 0.1 mg/kg titrated to response, with maximum single dose of 20 mg and maximum daily dose of 160 mg.

Conditions

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Postoperative Analgesia Cesarean Delivery Ketorolac

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ketorolac 30

patients will receive intravenous ketorolac at 30 mg/8 h postoperatively

Group Type ACTIVE_COMPARATOR

Ketorolac 30 mg

Intervention Type DRUG

administered intravenously as 30 mg diluted in 10 mL of normal saline and injected over more than 15 seconds

ketorolac 15 mg

patients will receive intravenous ketorolac at 15 mg/8 h postoperatively

Group Type ACTIVE_COMPARATOR

Ketorolac 15mg

Intervention Type DRUG

administered intravenously as either 15 mg diluted in 10 mL of normal saline and injected over more than 15 seconds.

Interventions

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Ketorolac 30 mg

administered intravenously as 30 mg diluted in 10 mL of normal saline and injected over more than 15 seconds

Intervention Type DRUG

Ketorolac 15mg

administered intravenously as either 15 mg diluted in 10 mL of normal saline and injected over more than 15 seconds.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* full-term, singleton, pregnant women,
* aged 18-35 years,
* scheduled for elective cesarean delivery under spinal anesthesia

Exclusion Criteria

* American Society of Anesthesiologists (ASA) physical class III or more
* multiple gestation. Patients with a history of allergy to any of the study drugs,
* renal impairment,
* gastrointestinal bleeding or ulceration
* inflammatory bowel disease,
* chronic pain or regular opioid use.
* Inability to comprehend the numeric pain scale (NRS) or the ObsQoR-11 score
* requirement for conversion to general anesthesia after spinal anesthesia
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Hasanin

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ahmed hasanin

Role: PRINCIPAL_INVESTIGATOR

Cairo University Kasr Alainy Faculty of Medicine

Locations

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Kasr Alainy Hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Maha Mostafa, MD

Role: CONTACT

+201000365115 ext. +2

Facility Contacts

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ahmed hasanin

Role: primary

01095076954 ext. +2

Other Identifiers

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MS-390-2025

Identifier Type: -

Identifier Source: org_study_id

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