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

NCT07244757 | Recruiting

• 1 other identifier: MS-390-2025
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ketorolac; Postoperative Analgesia; Cesarean Delivery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• numeric rating scale at rest

  at 30 minutes, 12-, 18-, and 24 hours postoperatively

• numeric rating scale during movement

  at 30 minutes, 6-, 12-, 18-, and 24 hours postoperatively

• total nalbuphine consumption

  from 0.5 hour postoperatively to 24 hour postoperatively

• time to first analgesic requirement

  time from immediately postoperatively to time of first analgesic requirement during the first 24 hours

• ObsQoR-11 score

  24 hour postoperatively

Study Arms (2)

ketorolac 30

ACTIVE COMPARATOR

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

Drug: Ketorolac 30 mg

ketorolac 15 mg

ACTIVE COMPARATOR

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

Drug: Ketorolac 15mg

Interventions

Ketorolac 30 mg DRUG

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

ketorolac 30

Ketorolac 15mg DRUG

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

ketorolac 15 mg

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy Hospital

Cairo, 11562, Egypt

RECRUITING

MeSH Terms

Interventions

Ketorolac

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• ahmed hasanin

  Cairo University Kasr Alainy Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maha Mostafa, MD

CONTACT

+201000365115; maha.mostafa@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 24, 2025
• Study Start: December 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)