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

Cairo University (CU)

Status: Enrolling

Conditions: Ketorolac; Postoperative Analgesia; Cesarean Delivery

Treatments: Drug: Ketorolac 30 mg; Drug: Ketorolac 15mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07244757

MS-390-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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126 participants in 2 patient groups

ketorolac 30

Active Comparator group

Description:

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

Treatment:

Drug: Ketorolac 30 mg

ketorolac 15 mg

Active Comparator group

Description:

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

Treatment:

Drug: Ketorolac 15mg