Comparison of Two Dosing Regimens of Intravenous Ketorolac for Post-Cesarean Pain Control: A Randomized Controlled Trial
| Registry | NCT07244757 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: quadruple, prevention |
| Enrollment | 125 (Actual) |
| Sponsor | Cairo University (Other) |
| Conditions | Postoperative Analgesia, Cesarean Delivery, Ketorolac |
| Interventions | Ketorolac 30 mg, Ketorolac 15mg (Drug) |
| Dates | start 2025-12-01, primary completion 2026-04-28, completion 2026-04-29, first posted 2025-11-24, last updated 2026-06-17 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Postoperative Analgesia All trials for Cesarean Delivery All trials of Ketorolac 30 mg All trials of Ketorolac 15mg
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ketorolac 30 | Active comparator | Drug: Ketorolac 30 mg | patients will receive intravenous ketorolac at 30 mg/8 h postoperatively |
| ketorolac 15 mg | Active comparator | Drug: Ketorolac 15mg | patients will receive intravenous ketorolac at 15 mg/8 h postoperatively |
Sex: Female, ages: 18 Years to 35 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Kasr Alainy Hospital | Cairo | Egypt |