Actively Recruiting

Phase Not Applicable
Age: 18Years - 35Years
FEMALE
ID07244757

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

Led by Cairo University · Updated on 2026-01-13

126

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

This research aims to compare the pain-relieving effects of two intravenous ketorolac dosing schedules as part of a combined pain management plan that includes local wound anesthesia after planned cesarean delivery. The study focuses on women aged 18 to 35 undergoing elective cesarean sections with spinal anesthesia to better understand how different ketorolac doses control postoperative pain. Participants will receive spinal anesthesia with bupivacaine and fentanyl, followed by a single dose of dexamethasone together with the first intravenous ketorolac dose after delivery. They will be randomly assigned to receive either 30 mg or 15 mg of intravenous ketorolac every 8 hours postoperatively. The surgical wound's subcutaneous layer will be numbed with bupivacaine, and additional pain medication nalbuphine will be given as needed based on pain scores. During the study, pain levels will be regularly measured using a numeric rating scale at rest and during movement at various times up to 24 hours after surgery. Researchers will track total nalbuphine use, time to first additional pain medication, quality of recovery scores, and patient satisfaction. The study uses a randomized and quadruple-masked design, with careful monitoring of participants’ responses to the different ketorolac doses over the first day following surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 35Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Full-term, singleton pregnant women
  • Aged 18 to 35 years
  • Scheduled for elective cesarean delivery under spinal anesthesia
Not Eligible

You will not qualify if you...

  • American Society of Anesthesiologists (ASA) physical class III or higher
  • Multiple gestation pregnancy
  • History of allergy to any study drugs
  • Renal impairment
  • Gastrointestinal bleeding or ulceration
  • Inflammatory bowel disease
  • Chronic pain or regular opioid use
  • Inability to understand the numeric pain scale or ObsQoR-11 score
  • Need for conversion to general anesthesia after spinal anesthesia

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 24 hours postoperatively

Participants receive intravenous ketorolac for post-cesarean pain control every 8 hours after delivery along with a single dose of dexamethasone and local anesthesia infiltration.

1 baseline visit and multiple assessments during the first 24 hours postoperatively

Trial Site Locations

Total: 1 location

1

Kasr Alainy Hospital

Cairo, Egypt, 11562

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Research Team

M

Maha Mostafa, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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