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

NCT07244757 — Not applicable, Completed, 125 participants, Cairo University

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

RegistryNCT07244757
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: quadruple, prevention
Enrollment125 (Actual)
SponsorCairo University (Other)
ConditionsPostoperative Analgesia, Cesarean Delivery, Ketorolac
InterventionsKetorolac 30 mg, Ketorolac 15mg (Drug)
Datesstart 2025-12-01, primary completion 2026-04-28, completion 2026-04-29, first posted 2025-11-24, last updated 2026-06-17
Locations1 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

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
ketorolac 30Active comparatorDrug: Ketorolac 30 mgpatients will receive intravenous ketorolac at 30 mg/8 h postoperatively
ketorolac 15 mgActive comparatorDrug: Ketorolac 15mgpatients will receive intravenous ketorolac at 15 mg/8 h postoperatively
  • Ketorolac 30 mg (Drug): administered intravenously as 30 mg diluted in 10 mL of normal saline and injected over more than 15 seconds
  • Ketorolac 15mg (Drug): administered intravenously as either 15 mg diluted in 10 mL of normal saline and injected over more than 15 seconds.

+Outcome measures

Primary outcomes

  • numeric rating scale at rest [6 hours postoperatively]: the patient rates their pain on a scale of 0 to 10, with 0 being "no pain" and 10 being the "worst pain imaginable"

Secondary outcomes

  • numeric rating scale at rest [at 30 minutes, 12-, 18-, and 24 hours postoperatively]: person rates their pain on a scale of 0 to 10, with 0 being "no pain" and 10 being the "worst pain imaginable"
  • numeric rating scale during movement [at 30 minutes, 6-, 12-, 18-, and 24 hours postoperatively]: 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
  • total nalbuphine consumption [from 0.5 hour postoperatively to 24 hour postoperatively]: mg
  • time to first analgesic requirement [time from immediately postoperatively to time of first analgesic requirement during the first 24 hours]: hours
  • ObsQoR-11 score [24 hour postoperatively]: 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
  • patient's satisfaction [24 hour postoperatively]: 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

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
Kasr Alainy HospitalCairoEgypt

+Investigators

  • ahmed hasanin, Principal investigator, Cairo University Kasr Alainy Faculty of Medicine