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

Comparison of Two Dosing Regimens of Intravenous Ketorolac for Post-Cesarean Pain Control: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Analgesia; Cesarean Delivery; Ketorolac
• Intervention / Treatment: Drug: Ketorolac 30 mg; Drug: Ketorolac 15mg

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maha Mostafa, MD; Phone Number: +2 +201000365115; Email: maha.mostafa@cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Recruiting
    • Kasr Alainy Hospital
    • Contact: ahmed hasanin; Phone Number: +2 01095076954; Email: ahmedmohamedhasanin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ketorolac 30; patients will receive intravenous ketorolac at 30 mg/8 h postoperatively	Drug: Ketorolac 30 mg; administered intravenously as 30 mg diluted in 10 mL of normal saline and injected over more than 15 seconds
Active Comparator: ketorolac 15 mg; patients will receive intravenous ketorolac at 15 mg/8 h postoperatively	Drug: Ketorolac 15mg; administered intravenously as either 15 mg diluted in 10 mL of normal saline and injected over more than 15 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numeric rating scale at rest	the patient rates their pain on a scale of 0 to 10, with 0 being "no pain" and 10 being the "worst pain imaginable"	6 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numeric rating scale at rest	person rates their pain on a scale of 0 to 10, with 0 being "no pain" and 10 being the "worst pain imaginable"	at 30 minutes, 12-, 18-, and 24 hours postoperatively
numeric rating scale during movement	person rates their pain on a scale of 0 to 10, with 0 being "no pain" and 10 being the "worst pain imaginable" during change position from supine to sitting or ambulation	at 30 minutes, 6-, 12-, 18-, and 24 hours postoperatively
total nalbuphine consumption	mg	from 0.5 hour postoperatively to 24 hour postoperatively
time to first analgesic requirement	hours	time from immediately postoperatively to time of first analgesic requirement during the first 24 hours
ObsQoR-11 score	The ObsQoR-11 is an 11-item questionnaire to assess a patient's recovery after a C-section, with a total score ranging from 0 to 100, where 100 is the best possible recovery	24 hour postoperatively
patient's satisfaction	At the end of the study the patient will be asked to rate her satisfaction with pain control using the NRS 10= strongly unsatisfied, 0= strongly satisfied	24 hour postoperatively

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: ahmed hasanin, Cairo University Kasr Alainy Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Estimated): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 10, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indomethacin; Indoles; Ketorolac
• Other Study ID Numbers: MS-390-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: data used for analysis will be available from the PI upon reasonable requist
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No