Skip to main content
OpenTrials
Completed

NCT Number: NCT07244757

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Analgesia Cesarean Delivery Ketorolac

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alainy Hospital

Cairo, 11562, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. numeric rating scale at rest

    Time frame: 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

  1. numeric rating scale at rest

    Time frame: 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"

  2. numeric rating scale during movement

    Time frame: 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

  3. total nalbuphine consumption

    Time frame: from 0.5 hour postoperatively to 24 hour postoperatively

    mg

  4. time to first analgesic requirement

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

    hours

  5. ObsQoR-11 score

    Time frame: 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

  6. patient's satisfaction

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2025
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.