NCT05248984

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

June 8, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

February 25, 2026

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

1.5 years

First QC Date

February 9, 2022

Results QC Date

January 22, 2026

Last Update Submit

February 24, 2026

Conditions

Post Cesarean Pain

Keywords

Postoperative painCesareanKetorolac

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Comparing the Morphine Milligram Equivalents (MME) Use During Hospital Stay.

    After cesarean surgery during hospital stay up to 2-3 days.

  • Comparing Patient Reported Pain Score Assessment.

    After cesarean surgery up to 24 hours.

  • Comparing the Time to First Administration of Opioid Pain Medication Postoperatively.

    After cesarean surgery up to 2-3 days.

  • Pain Score on Discharge Home

    After cesarean surgery during hospital stay up to 2-3 days.

  • Number of Participants With Adverse Maternal Outcomes.

    After cesarean surgery during hospital stay up to 2-3 days.

  • +1 more secondary outcomes

Study Arms (2)

Ketorolac 30 mg

EXPERIMENTAL

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

Drug: Ketorolac 30 Mg

Ketorolac 60 mg

EXPERIMENTAL

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

Drug: Ketorolac 60 Mg

Interventions

Ketorolac 30 MgDRUG

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

Ketorolac 30 mg
Ketorolac 60 MgDRUG

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

Ketorolac 60 mg

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • 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.

    PMID: 41908170DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketorolac

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Kara Rood
Organization
The Ohio State University
Kara.Rood@osumc.edu
440-321-0264

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 9, 2022

First Posted

February 21, 2022

Study Start

June 8, 2022

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

February 25, 2026

Results First Posted

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)