Two intravenous ketorolac dosing schedules for pain after cesarean delivery
Comparison of Two Dosing Regimens of Intravenous Ketorolac for Post-Cesarean Pain Control: A Randomized Controlled Trial
NA · Cairo University · NCT07244757
This trial will test whether two IV ketorolac dosing schedules provide better pain relief after elective cesarean delivery for full-term women.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Cairo University (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07244757 on ClinicalTrials.gov |
What this trial studies
Participants receive spinal anesthesia (10 mg hyperbaric bupivacaine 0.5% plus 25 mcg fentanyl) with prophylactic vasopressor, and after delivery all receive 8 mg dexamethasone plus the first IV ketorolac dose. Patients are randomized to receive either 15 mg or 30 mg IV ketorolac, with subsequent doses every 8 hours as part of a multimodal analgesic protocol that includes local wound infiltration with 30 mL of 0.25% bupivacaine at fascial closure. Postoperative pain is managed using a Numeric Rating Scale and rescue IV nalbuphine (0.1 mg/kg, titrated) if pain exceeds 3. The main comparison is analgesic efficacy and opioid‑sparing effect between the two ketorolac regimens after elective cesarean delivery.
Who should consider this trial
Good fit: Full-term, singleton pregnant women aged 18–35 scheduled for elective cesarean under spinal anesthesia who have no contraindications to NSAIDs or the protocol medications.
Not a fit: Women with renal impairment, active gastrointestinal bleeding or ulceration, inflammatory bowel disease, chronic opioid use, allergy to study drugs, or those who require conversion to general anesthesia are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could improve post-cesarean pain control and reduce opioid use by identifying an optimal ketorolac dose.
How similar studies have performed: Previous studies show ketorolac is effective and opioid‑sparing for postoperative analgesia, but direct comparisons of 15 mg versus 30 mg dosing after cesarean are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cairo
- Kasr Alainy Hospital — Cairo, Egypt (RECRUITING)
Study contacts
- Principal investigator: ahmed hasanin — Cairo University Kasr Alainy Faculty of Medicine
- Study coordinator: Maha Mostafa, MD
- Email: maha.mostafa@cu.edu.eg
- Phone: +201000365115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postoperative Analgesia, Cesarean Delivery, Ketorolac