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To evaluate the efficacy of increased ketorolac in reducing opioid use after cesarean section.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | The intervention is a protocol of scheduled IV Ketorolac administered postoperatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 72 postoperative hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36897140 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Protocol | 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. |
| FG001 | Ketorolac Protocol | 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. Ketorolac: The intervention is a protocol of scheduled IV Ketorolac administered postoperatively. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Protocol | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | Posted | Median | Inter-Quartile Range | MME | Within 72 postoperative hours |
|
Up to 6 weeks postpartum
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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 | Standard Protocol | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment | One patient in the ketorolac group was admitted postpartum with a headache. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean Hostage | Tufts Medical Center | 617-636-4549 | jeanhostage@gmail.com |
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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 | Feb 15, 2022 | May 12, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 14, 2021 | May 12, 2022 | ICF_001.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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Randomized controlled trial
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The subjects, care providers, and investigators will be blinded to the assignments of groups.
| 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. | Within 72 post-operative hours |
| Postoperative Change in Hematocrit | The change in patient hematocrit from baseline to POD1 | Change in pre-operative hematocrit to POD1 hematocrit |
| Change in Creatinine | The change in patient's creatinine from POD1 to POD2 | 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. | 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. | Satisfaction with inpatient care as reported at two weeks postpartum |
| BG001 |
| Ketorolac Protocol |
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. Ketorolac: The intervention is a protocol of scheduled IV Ketorolac administered postoperatively. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects randomized to the Ketorolac protocol will receive the study postoperative pain protocol. This includes 5 doses of IV Ketorolac, scheduled every 6 hours. The first dose is administered in the operating room. Ketorolac: The intervention is a protocol of scheduled IV Ketorolac administered postoperatively. |
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Secondary | The Number of Patients That Used no Opioid Postoperatively | The number of patients in each arm that required no opioids for pain control postoperatively. | Posted | Count of Participants | Participants | Within 72 post-operative hours |
|
|
|
| Secondary | Postoperative Change in Hematocrit | The change in patient hematocrit from baseline to POD1 | Post-operative day 1 hematocrit was available on 72 patients in the standard group and 73 patients in the ketorolac group. | Posted | Mean | Standard Deviation | percentage of red blood cells in blood | Change in pre-operative hematocrit to POD1 hematocrit |
|
|
|
| Secondary | Change in Creatinine | The change in patient's creatinine from POD1 to POD2 | Post operative day 1 and 2 creatinine was collected on 68 patients in the standard group and 65 patients in the ketorolac group. | Posted | Mean | Standard Deviation | mg/dL | Change in creatinine from POD1 to POD2 |
|
|
|
| Secondary | 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. | 52 patients in the standard protocol and 52 patients in the ketorolac group responded to the 2 week postpartum survey. | Posted | Count of Participants | Participants | Inpatient pain control satisfaction as reported at two weeks postpartum |
|
|
|
| Secondary | 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. | 52 patients in the standard protocol and 52 patients in the ketorolac group responded to the 2 week postpartum survey. | Posted | Count of Participants | Participants | Satisfaction with inpatient care as reported at two weeks postpartum |
|
|
|
| 0 |
| 74 |
| 1 |
| 74 |
| 0 |
| 74 |
| EG001 | Ketorolac Protocol | 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. Ketorolac: The intervention is a protocol of scheduled IV Ketorolac administered postoperatively. | 0 | 74 | 1 | 74 | 0 | 74 |
|
| Endometritis | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | One patient in the placebo group developed endometritis |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 | Heterocyclic Compounds |