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

NCT ID: NCT05248984

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-08
• Study Completion Date: 2023-11-30

Brief Summary

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.

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.

Conditions

Post Cesarean Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ketorolac 30 mg

Participants will receive single dose of intravenous (IV) Ketorolac 30mg

Group Type: ACTIVE_COMPARATOR

Ketorolac

Intervention Type: DRUG

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 intravenous (IV) Ketorolac 30mg Vs.
• Single dose of intravenous (IV) Ketorolac 60mg

Ketorolac 60 mg

Participants will receive single dose of intravenous (IV) Ketorolac 60mg

Group Type: ACTIVE_COMPARATOR

Ketorolac

Intervention Type: DRUG

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 intravenous (IV) Ketorolac 30mg Vs.
• Single dose of intravenous (IV) Ketorolac 60mg

Interventions

Ketorolac

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 intravenous (IV) Ketorolac 30mg Vs.
• Single dose of intravenous (IV) Ketorolac 60mg

Intervention Type: DRUG

Eligibility Criteria

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)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Kara M Rood, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2022H0063

Identifier Type: -

Identifier Source: org_study_id