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

Completed

• Conditions: Post Cesarean Pain
• Interventions: Drug: Ketorolac

• Registration Number: NCT05248984
• Lead Sponsor: Ohio State University

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.

Study Timeline

• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-21
• Study Start: 2022-06-08
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 92

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ketorolac 30 mg	Ketorolac	Participants will receive single dose of intravenous (IV) Ketorolac 30mg
Ketorolac 60 mg	Ketorolac	Participants will receive single dose of intravenous (IV) Ketorolac 60mg

Primary Outcome Measures

Name	Time	Method
Comparing the morphine milligram equivalents (MME) use in the first 24 hours. postoperatively after cesarean section	After cesarean surgery up to 24 hours.	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.

Secondary Outcome Measures

Name	Time	Method
Comparing patient reported pain score assessment.	After cesarean surgery up to 24 hours.	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.
Comparing the morphine milligram equivalents (MME) use during hospital stay.	After cesarean surgery during hospital stay up to 2-3 days.	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.
Comparing the time to first administration of opioid pain medication postoperatively.	After cesarean surgery up to 2-3 days.	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.
Evaluating adverse maternal outcomes.	After cesarean surgery during hospital stay up to 2-3 days.	Evaluating adverse maternal outcomes (acute kidney injury, admission to intensive care unit, maternal death).
Evaluating type of skin incision.	After cesarean surgery during hospital stay up to 2-3 days.	Evaluating type of skin incision (Pfannenstiel vs. Vertical Midline).

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine; 🇺🇸 Columbus, Ohio, United States