Scheduled Ketorolac Administration and Its Effect on Opioid Consumption
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Post-Surgical Pain, Hospital |
| Therapuetic Areas: | Musculoskeletal, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 12/27/2018 |
| Start Date: | January 2019 |
| End Date: | July 2019 |
Scheduled Ketorolac Administration After Cesarean Section and Its Effect on Opioid Consumption: a Randomized Control Trial
This study evaluates how a protocol of scheduled non-narcotic anesthetic used in the
immediate post-operative period affects the average patient pain scale scores and the amount
of oral narcotic medication administered. The objective of the study is to identify a
post-operative pain control regimen that can decrease the amount of oral narcotic medications
administered in the post-operative period.
The primary outcome will be the amount of morphine milligram equivalents (MME) used in each
group. Secondary outcomes will include pain scores, postoperative complete blood count, and
post-operative satisfaction with care received during admission.
immediate post-operative period affects the average patient pain scale scores and the amount
of oral narcotic medication administered. The objective of the study is to identify a
post-operative pain control regimen that can decrease the amount of oral narcotic medications
administered in the post-operative period.
The primary outcome will be the amount of morphine milligram equivalents (MME) used in each
group. Secondary outcomes will include pain scores, postoperative complete blood count, and
post-operative satisfaction with care received during admission.
Subjects who consented to be part of the trial will be randomized at the time of skin closure
of their cesarean section to either the standard group or the study group. The standard group
will receive the standard treatment of 2 doses of 30mg IV Ketorolac on an as needed basis.
The study group will receive 5 doses of 30mg IV Ketorolac scheduled every 6 hours. The
subject will receive her first dose in the operating room. The ob/gyn residents will be
responsible for placing the orders in Sorian for either "Standard Post-Operative Pain
Control" order set or the "Ketorolac Study Post Cesarean Section Pain Control" order set.
Please see below for sample order sets. Pain scores will be evaluated using a visual analog
pain scale every 6 hours throughout hospitalization and recorded in the electronic medical
record. The amount of oral opiate medications administered for subjects in each group will be
recorded in the electronic medical record as well.
of their cesarean section to either the standard group or the study group. The standard group
will receive the standard treatment of 2 doses of 30mg IV Ketorolac on an as needed basis.
The study group will receive 5 doses of 30mg IV Ketorolac scheduled every 6 hours. The
subject will receive her first dose in the operating room. The ob/gyn residents will be
responsible for placing the orders in Sorian for either "Standard Post-Operative Pain
Control" order set or the "Ketorolac Study Post Cesarean Section Pain Control" order set.
Please see below for sample order sets. Pain scores will be evaluated using a visual analog
pain scale every 6 hours throughout hospitalization and recorded in the electronic medical
record. The amount of oral opiate medications administered for subjects in each group will be
recorded in the electronic medical record as well.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Provider decision to exclude patient.
- A study subject may participate in another research study while participating in this
research study.
We found this trial at
1
site
800 Washington St
Boston, Massachusetts 02111
Boston, Massachusetts 02111
(617) 636-5000
Phone: 617-636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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