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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Post Cesarean Pain

Intervention / Treatment
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* Drug: Ketorolac


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ketorolac 30 mg<br>Participants will receive single dose of intravenous (IV) Ketorolac 30mg | Drug: Ketorolac<br>* 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<br>|
| Ketorolac 60 mg<br>Participants will receive single dose of intravenous (IV) Ketorolac 60mg | Drug: Ketorolac<br>* 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<br>|

What is the study measuring?
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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. | 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. | 
| Evaluating 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, Cesarean, Ketorolac