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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketorolac 30 mg | Experimental | Participants will be assigned of single dose of intravenous (IV) Ketorolac 30mg |
|
| Ketorolac 60 mg | Experimental | Participants will be assigned of single dose of intravenous (IV) Ketorolac 60mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac 30 Mg | Drug | Participants will receive single dose of intravenous (IV) Ketorolac 30mg |
|
| 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. |
| 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. |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41908170 | Derived | Eid J, Caplan M, Goel N, Poirier MV, Montaine-O'Brien S, Rood KM, Costantine MM. Two Perioperative Ketorolac Dosing Regimens After Cesarean Delivery and Opioid Use: A Randomized Controlled Trial. O G Open. 2026 Mar 26;3(2):e159. doi: 10.1097/og9.0000000000000159. eCollection 2026 Apr. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketorolac 30 mg | Participants will be assigned of single dose of intravenous (IV) Ketorolac 30mg Ketorolac 30 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 30mg |
| FG001 | Ketorolac 60 mg | Participants will be assigned of single dose of intravenous (IV) Ketorolac 60mg Ketorolac 60 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 60mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketorolac 30 mg | Participants will be assigned of single dose of intravenous (IV) Ketorolac 30mg Ketorolac 30 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 30mg |
| BG001 | Ketorolac 60 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | Morphine milligram equivalents | After cesarean surgery up to 24 hours. |
|
After cesarean surgery during hospital stay up to 2-3 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketorolac 30 mg | Participants will be assigned of single dose of intravenous (IV) Ketorolac 30mg Ketorolac 30 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 30mg |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kara Rood | The Ohio State University | 440-321-0264 | Kara.Rood@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2023 | Jan 22, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Single blinded
| Ketorolac 60 Mg | Drug | Participants will receive single dose of intravenous (IV) Ketorolac 60mg |
|
| 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
| 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
| 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. |
Participants will be assigned of single dose of intravenous (IV) Ketorolac 60mg
Ketorolac 60 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 60mg
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants will be assigned of single dose of intravenous (IV) Ketorolac 60mg
Ketorolac 60 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 60mg
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | Morphine milligram equivalents | After cesarean surgery during hospital stay up to 2-3 days. |
|
|
|
| Secondary | 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
| Posted | Median | Inter-Quartile Range | Scores on a scale | After cesarean surgery up to 24 hours. |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | Hours | After cesarean surgery up to 2-3 days. |
|
|
|
| Secondary | 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
| Posted | Median | Inter-Quartile Range | Scores on a scale | After cesarean surgery during hospital stay up to 2-3 days. |
|
|
|
| Secondary | Number of Participants With Adverse Maternal Outcomes. | Evaluating adverse maternal outcomes (acute kidney injury, admission to intensive care unit, maternal death). | Posted | Count of Participants | Participants | After cesarean surgery during hospital stay up to 2-3 days. |
|
|
|
| Secondary | Evaluating Type of Skin Incision. | Evaluating type of skin incision (Pfannenstiel vs. Vertical Midline). | Posted | Count of Participants | Participants | After cesarean surgery during hospital stay up to 2-3 days. |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Ketorolac 60 mg | Participants will be assigned of single dose of intravenous (IV) Ketorolac 60mg Ketorolac 60 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 60mg | 0 | 46 | 0 | 46 | 0 | 46 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 | Heterocyclic Compounds |