AzTrials
AzTrials

Post Cesarean PainPhase 4KINGNCT05248984

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

A Phase 4 study testing Ketorolac 30 Mg and Ketorolac 60 Mg in people with Post Cesarean Pain, run by Ohio State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Post Cesarean Pain
What is being tested?
Ketorolac 30 Mg and Ketorolac 60 Mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteUnited States
Study dates
8 Jun 2022to 30 Nov 2023
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult
  1. 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)
  1. 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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Columbus, Ohio, 43210

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Ketorolac 30 Mg, Ketorolac 60 Mg
Keywords
Postoperative pain, Cesarean, Ketorolac
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ketorolac 30 MgDrug

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

  • Ketorolac 60 MgDrug

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

Study groups in NCT05248984
Study groupRoleWhat they receive
Ketorolac 30 mgExperimentalParticipants will be assigned of single dose of intravenous (IV) Ketorolac 30mg
Receives: Drug: Ketorolac 30 Mg
Ketorolac 60 mgExperimentalParticipants will be assigned of single dose of intravenous (IV) Ketorolac 60mg
Receives: Drug: Ketorolac 60 Mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: After cesarean surgery up to 24 hours.

Secondary outcomes (6)

  1. 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.

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

  2. 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

    1. Hardly notice pain
    2. Notice pain does not interfere with activities
    3. Sometimes distracts me
    4. Distracts me, can do usual activities
    5. Interrupts some activities
    6. Hard to ignore, avoid usual activities
    7. Focus of attention, prevents doing daily activities
    8. Awful, hard to do anything
    9. Can't bear the pain, unable to do anything
    10. As bas as it could be nothing else matters

    Measured: After cesarean surgery up to 24 hours.

  3. 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.

    Measured: After cesarean surgery up to 2-3 days.

  4. 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

    1. Hardly notice pain
    2. Notice pain does not interfere with activities
    3. Sometimes distracts me
    4. Distracts me, can do usual activities
    5. Interrupts some activities
    6. Hard to ignore, avoid usual activities
    7. Focus of attention, prevents doing daily activities
    8. Awful, hard to do anything
    9. Can't bear the pain, unable to do anything
    10. As bas as it could be nothing else matters

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

  5. Number of Participants With Adverse Maternal Outcomes.

    Evaluating adverse maternal outcomes (acute kidney injury, admission to intensive care unit, maternal death).

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

  6. Evaluating Type of Skin Incision.

    Evaluating type of skin incision (Pfannenstiel vs. Vertical Midline).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2022
  2. Study start8 Jun 2022
  3. Primary completion30 Nov 2023
  4. Study completion30 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05248984
Sponsor's protocol ID
2022H0063
Acronym
KING
Status last verified
Feb 2026
First submitted
9 Feb 2022
Last updated
25 Feb 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41908170

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ketorolac 30 Mg and Ketorolac 60 Mg in people with Post Cesarean Pain, run by Ohio State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparing the Morphine Milligram Equivalents (MME) Use in the First 24 Hours. Postoperatively After Cesarean Section (time frame: After cesarean surgery up to 24 hours.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05248984, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in