Post-operative PainPhase 3NCT03678675
Increased Ketorolac Administration After Cesarean Section and Its Effect on Opioid Use: a Randomized Control Trial
A Phase 3 study testing Ketorolac in people with Post-operative Pain and Post-partum Pain, run by Tufts Medical Center at 1 site in United States.
Trial summary
To evaluate the efficacy of increased ketorolac in reducing opioid use after cesarean section. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain, Post-partum Pain, Cesarean Section Complications
- What is being tested?
- Ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2019to 30 Jun 2022
- Phase
- Phase 3
- 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women presenting for care at Tufts Medical Center as an outpatient in obstetrics clinic or on Labor and Delivery.
- The subject must have had a cesarean section for any indication at Tufts Medical Center to be randomized to the study
- The subject is willing to have a phone call follow up conversation 2 weeks after their surgery.
Who cannot join
- Patients with allergy to ketorolac, NSAIDS or aspirin
- Patients with peptic ulcer disease, preexisting kidney or liver disease.
- Duramorph is not used as the anesthetic for the spinal/epidural during the cesarean section.
- Patient is hemodynamically unstable due to hemorrhage.
- Patient requires therapeutic anticoagulation in the post-operative period
- Patients with peripartum cardiomyopathy
Show all 9Show fewer
- Provider decision to exclude patient.
- Patient diagnosis of chronic hypertension, gestational hypertension, preeclampsia, HELLP syndrome, or eclampsia
- A study subject may participate in another research study while participating in this research study.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the efficacy of increased ketorolac in reducing opioid use after cesarean section.
Read the detailed description
This was a single-center, randomized, double-blind, parallel-group trial to assess pain management following cesarean section with increased ketorolac versus placebo. All patients undergoing cesarean section with neuraxial anesthesia received two doses of 30mg IV ketorolac postoperatively per hospital protocol and were then randomized to receive an additional four doses of 30 mg of IV ketorolac or placebo every 6 hours. The primary outcome was the total morphine milligram equivalents (MME) used in the first 72 postoperative hours. Secondary outcomes included the number of patients that used no opioid postoperatively, postoperative pain scores, postoperative change in hematocrit and creatinine, and postoperative satisfaction with inpatient care and pain management. A sample size of 74 per group (n=148) was planned.
- Being tested
- Ketorolac
- Keywords
- ketorolac, opiate, cesarean section
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Standard Protocol | No intervention | Subjects randomized to the standard group will receive the standard postoperative pain protocol that is currently used at Tufts Medical Center. It includes two doses of IV Ketorolac every 6 hours as needed for postoperative pain. Ibuprofen would be ordered 6 hours following the last dose after the last study drug. |
| Ketorolac Protocol | Experimental | Subjects randomized to the Ketorolac protocol will receive the study postoperative pain protocol. This includes 6 doses of IV Ketorolac, scheduled every 6 hours. The first dose is administered in the operating room or post-operative care unit. Receives: Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Total Morphine Milligram Equivalents (MME) Used in the First 72 Postoperative Hours
The amount of MME's will be monitored for each group. MME's will be determined by the amount of opiate mediations administered. The MME value can range from 0 to typically 200 MME's, however there is no upper limit of measureable MME's. The MME's for each patient will be a sum of MME's administered throughout the course of the hospitalization.
Measured: Within 72 postoperative hours
Secondary outcomes (6)
Number of Participants With a Pain Score Greater Than 3
The patient reported pain scores will be recorded and analyzed for each group. The Pain Score is determined by the patient using a visual analog scale with a range from 0-10, where 0 is no pain at all and 10 is the worst pain imaginable for the patient. Pain scores were collected by postpartum nursing staff per institutional policy. The number of patients with a pain score greater than 3 will be reported. A pain score greater than 3 was chosen as a cutoff as this is the pain score at which an opioid may be indicated for analgesia at our institution.
Measured: 2 weeks
The Number of Patients That Used no Opioid Postoperatively
The number of patients in each arm that required no opioids for pain control postoperatively.
Measured: Within 72 post-operative hours
Postoperative Change in Hematocrit
The change in patient hematocrit from baseline to POD1
Measured: Change in pre-operative hematocrit to POD1 hematocrit
Change in Creatinine
The change in patient's creatinine from POD1 to POD2
Measured: Change in creatinine from POD1 to POD2
Postoperative Satisfaction With Inpatient Pain Control
Two weeks after cesarean section, subjects were contacted by telephone to complete a survey on postpartum pain management. At least three attempts were made to contact subjects by telephone. In the follow-up phone call, patients were asked to rate their satisfaction with their postpartum care: very satisfied, satisfied, neutral, dissatisfied, or very dissatisfied. The number below describes the number of patients who reported they were "very satisfied" with their care.
Measured: Inpatient pain control satisfaction as reported at two weeks postpartum
Postoperative Satisfaction With Their Inpatient Postpartum Care.
Two weeks after cesarean section, subjects were contacted by telephone to complete a survey on their overall postpartum care. At least three attempts were made to contact subjects by telephone. In the follow-up phone call, patients were asked to rate their satisfaction with their postpartum care: very satisfied, satisfied, neutral, dissatisfied, or very dissatisfied. The number below describes the number of patients that reported they were very satisfied with their care.
Measured: Satisfaction with inpatient care as reported at two weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start30 May 2019
- Primary completion31 Jan 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678675
- Sponsor's protocol ID
- Ketorolac Pain Study
- Status last verified
- Jul 2022
- First submitted
- 17 Sep 2018
- Last updated
- 18 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hostage J, Kolettis D, Sverdlov D, Ludgin J, Drzymalski D, Sweigart B, Mhatre M, House M. Increased Scheduled Intravenous Ketorolac After Cesarean Delivery and Its Effect on Opioid Use: A Randomized Controlled Trial. Obstet Gynecol. 2023 Apr 1;141(4):783-790. doi: 10.1097/AOG.0000000000005120. Epub 2023 Mar 9.
PubMed 36897140
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Ketorolac Administration After Cesarean Section and Its Effect on Opioid Use: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03678675
- Acronym / sponsor ID
- Ketorolac Pain Study
- Keywords
- ketorolac, opiate, cesarean section
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- 30 May 2019 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Posted 18 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of increased ketorolac in reducing opioid use after cesarean section.
Detailed description
This was a single-center, randomized, double-blind, parallel-group trial to assess pain management following cesarean section with increased ketorolac versus placebo. All patients undergoing cesarean section with neuraxial anesthesia received two doses of 30mg IV ketorolac postoperatively per hospital protocol and were then randomized to receive an additional four doses of 30 mg of IV ketorolac or placebo every 6 hours. The primary outcome was the total morphine milligram equivalents (MME) used in the first 72 postoperative hours. Secondary outcomes included the number of patients that used no opioid postoperatively, postoperative pain scores, postoperative change in hematocrit and creatinine, and postoperative satisfaction with inpatient care and pain management. A sample size of 74 per group (n=148) was planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard Protocol | No intervention | –Subjects randomized to the standard group will receive the standard postoperative pain protocol that is currently used at Tufts Medical Center. It includes two doses of IV Ketorolac every 6 hours as needed for postoperative pain. Ibuprofen would be ordered 6 hours following the last dose after the last study drug. |
| Ketorolac Protocol | Experimental | Drug: KetorolacSubjects randomized to the Ketorolac protocol will receive the study postoperative pain protocol. This includes 6 doses of IV Ketorolac, scheduled every 6 hours. The first dose is administered in the operating room or post-operative care unit. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Women presenting for care at Tufts Medical Center as an outpatient in obstetrics clinic or on Labor and Delivery.
- The subject must have had a cesarean section for any indication at Tufts Medical Center to be randomized to the study
- The subject is willing to have a phone call follow up conversation 2 weeks after their surgery.
Key exclusion criteria (9 listed)
- Patients with allergy to ketorolac, NSAIDS or aspirin
- Patients with peptic ulcer disease, preexisting kidney or liver disease.
- Duramorph is not used as the anesthetic for the spinal/epidural during the cesarean section.
- Patient is hemodynamically unstable due to hemorrhage.
- Patient requires therapeutic anticoagulation in the post-operative period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetorolacThe intervention is a protocol of scheduled IV Ketorolac administered postoperatively. | Drug | Ketorolac Protocol |
Primary outcome
The Total Morphine Milligram Equivalents (MME) Used in the First 72 Postoperative Hours
Time frame: Within 72 postoperative hours
The amount of MME's will be monitored for each group. MME's will be determined by the amount of opiate mediations administered. The MME value can range from 0 to typically 200 MME's, however there is no upper limit of measureable MME's. The MME's for each patient will be a sum of MME's administered throughout the course of the hospitalization.
6 secondary outcomes
Number of Participants With a Pain Score Greater Than 3
Time frame: 2 weeks
The Number of Patients That Used no Opioid Postoperatively
Time frame: Within 72 post-operative hours
Postoperative Change in Hematocrit
Time frame: Change in pre-operative hematocrit to POD1 hematocrit
Change in Creatinine
Time frame: Change in creatinine from POD1 to POD2
Postoperative Satisfaction With Inpatient Pain Control
Time frame: Inpatient pain control satisfaction as reported at two weeks postpartum
Postoperative Satisfaction With Their Inpatient Postpartum Care.
Time frame: Satisfaction with inpatient care as reported at two weeks postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36897140Hostage J, Kolettis D, Sverdlov D, Ludgin J, Drzymalski D, Sweigart B, Mhatre M, House M. Increased Scheduled Intravenous Ketorolac After Cesarean Delivery and Its Effect on Opioid Use: A Randomized Controlled Trial. Obstet Gynecol. 2023 Apr 1;141(4):783-790. doi: 10.1097/AOG.0000000000005120. Epub 2023 Mar 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketorolac in people with Post-operative Pain and Post-partum Pain, run by Tufts Medical Center 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?
The sponsor lists 3 inclusion and 9 exclusion criteria. 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 18 Aug 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 18 Aug 2022). 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?
The Total Morphine Milligram Equivalents (MME) Used in the First 72 Postoperative Hours (time frame: Within 72 postoperative 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 NCT03678675, 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 18 Aug 2022; AzTrials last refreshed its copy on 26 Oct 2026.