Dosing of Ketorolac Impacts Post-cesarean paiN manaGemenet (KING) (KING)

Dosing of Ketorolac Impacts Post-cesarean paiN manaGemenet (KING): A Randomized Controlled Trial

This is a randomized controlled single blinded trial to compare the morphine milligram equivalents (MME) use in the first 24 hours postoperatively after cesarean section in patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room after the end of surgery.

Study Overview

• Status: Completed
• Conditions: Post Cesarean Pain
• Intervention / Treatment: Drug: Ketorolac 30 Mg; Drug: Ketorolac 60 Mg

Detailed Description

Administration of a dose of ketorolac for postoperative pain management at end of cesarean is routine practice at our institution.

This is a randomized controlled single blinded trial at The Ohio State University comparing a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room immediately after cesarean section.

Potential study participants will be identified at the time of admission to Labor and Delivery unit. Inclusion criteria must be met, namely patient's age, mode of delivery via cesarean section. The decision for mode of delivery will be at the discretion of the primary obstetrics (OB) provider. Indications for cesarean delivery would be: scheduled cesarean due to history of previous uterine surgery including prior cesarean section, failed induction of labor, arrest of second stage of labor, non-reassuring fetal status.

Patients will be approached for consent and enrollment when decision is made to proceed for cesarean section by their primary provider. Patients with allergy to Non-steroidal anti-inflammatory drugs (NSAIDs), history of opioid use disorder, chronic pain disorders, or undergoing an emergent Cesarean section, will be excluded from the study.

Once the decision has been made by the primary obstetrics (OB) provider to proceed with cesarean delivery, participants will be randomized in to one of two groups:

• Single dose of IV Ketorolac 30mg Vs.
• Single dose of IV Ketorolac 60mg

The intervention and primary outcome will take place over the span of 24 hour post-cesarean. Once enrolled and randomized, patients will be given either 60 mg or 30 mg of IV ketorolac at the end of the procedure. All other obstetric care will be at the discretion of the primary provider, including but not limited to pain management postoperatively. Analysis will be by intent to treat. The secondary outcomes will be collected during the hospital stay until discharge.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Study Population

Pregnant individuals undergoing a cesarean section at The Ohio State University Wexner Medical Center.

Description

1. Inclusion criteria:

   • Pregnant individuals aged 18-45 with a viable single or twin intrauterine pregnancy
   • Cesarean section as the delivery mode
   • Regional anesthesia (Spinal, Epidural, Combined Spinal Epidural)

2. Exclusion criteria:

   • Known allergy or adverse reaction to Non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or ketorolac
   • Patients with peptic ulcer disease, preexisting kidney or liver disease
   • Hemodynamically unstable due to hemorrhage
   • Acute or chronic pain disorder
   • Physician/provider or patient refusal
   • Estimated blood loss > 2000 mL
   • General anesthesia
   • Opioid use disorder
   • Emergent Cesarean delivery
   • Coagulation disorders
   • Active asthma
   • Patients weighing <50 kg

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketorolac 30 mg; Participants will be assigned of single dose of intravenous (IV) Ketorolac 30mg	Drug: Ketorolac 30 Mg; Participants will receive single dose of intravenous (IV) Ketorolac 30mg
Experimental: Ketorolac 60 mg; Participants will be assigned of single dose of intravenous (IV) Ketorolac 60mg	Drug: Ketorolac 60 Mg; Participants will receive single dose of intravenous (IV) Ketorolac 60mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing the Morphine Milligram Equivalents (MME) Use in the First 24 Hours. Postoperatively After Cesarean Section	Comparing the morphine milligram equivalents (MME) use in the first 24 hours postoperatively after cesarean section in patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room after the end of surgery.	After cesarean surgery up to 24 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing the Morphine Milligram Equivalents (MME) Use During Hospital Stay.	Comparing the morphine milligram equivalents (MME) use during hospital stay postoperatively after cesarean section in patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room after the end of surgery.	After cesarean surgery during hospital stay up to 2-3 days.
Comparing Patient Reported Pain Score Assessment.	Comparing patient reported pain score assessment on a scale of 0-10 in the first 24 hours postoperatively after cesarean section in patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room after the end of surgery. Pain scores postpartum from 0 to 10 based on the Defense and Veterans Pain Rating Scale (DVPRS). 0- No pain; Hardly notice pain; Notice pain does not interfere with activities; Sometimes distracts me; Distracts me, can do usual activities; Interrupts some activities; Hard to ignore, avoid usual activities; Focus of attention, prevents doing daily activities; Awful, hard to do anything; Can't bear the pain, unable to do anything; As bas as it could be nothing else matters	After cesarean surgery up to 24 hours.
Comparing the Time to First Administration of Opioid Pain Medication Postoperatively.	Comparing the time to first administration of opioid pain medication postoperatively after cesarean section in patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room after the end of surgery.	After cesarean surgery up to 2-3 days.
Pain Score on Discharge Home	Comparing the pain score on discharge home in patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room after the end of surgery. Pain scores postpartum from 0 to 10 based on the Defense and Veterans Pain Rating Scale (DVPRS). 0- No pain; Hardly notice pain; Notice pain does not interfere with activities; Sometimes distracts me; Distracts me, can do usual activities; Interrupts some activities; Hard to ignore, avoid usual activities; Focus of attention, prevents doing daily activities; Awful, hard to do anything; Can't bear the pain, unable to do anything; As bas as it could be nothing else matters	After cesarean surgery during hospital stay up to 2-3 days.
Number of Participants With Adverse Maternal Outcomes.	Evaluating adverse maternal outcomes (acute kidney injury, admission to intensive care unit, maternal death).	After cesarean surgery during hospital stay up to 2-3 days.
Evaluating Type of Skin Incision.	Evaluating type of skin incision (Pfannenstiel vs. Vertical Midline).	After cesarean surgery during hospital stay up to 2-3 days.

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Cesarean; Postoperative pain; Ketorolac
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indomethacin; Indoles; Ketorolac
• Other Study ID Numbers: 2022H0063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes