Cleveland, Ohio 44106


Purpose:

This is a randomized, double blind placebo trial to evaluate whether ketorolac given at the time of cord clamp has any impact on post-partum pain control. Patients will be randomized to either placebo or ketorolac prior to surgery. Those randomized to ketorolac will receive ketorolac at cord clamp and 3 additional doses 6 hours apart (total 4 doses/24 hours). Those in the placebo group will receive placebo medications during those time periods.


Study summary:

Screening/Eligibility Visit: Once the determination for Cesarean delivery has been made, either following admission to labor and delivery or during a prenatal clinic visit, based on clinical indication, the potential participant will be screened and eligibility will be confirmed by a study investigator. A signed, IRB-approved informed consent will be obtained. Cesarean Delivery: Cesarean delivery will be performed using the standard procedures established in MacDonald Women's Hospital by an attending physician or chief resident and a junior resident. Randomization and administration of study medication: Randomization will be performed by the research pharmacy. Subjects will be randomized in blocks of four. Upon arrival in the OR the anesthesiologist will open an envelope which will demonstrate the number medication the patient will receive based on a blinding key which the pharmacy will possess. At minimum, 6 sets of vials of either placebo or ketorolac will be held in the drug dispensary at any given time. The anesthesiologist or anesthetist will then pull the drug from the dispensary. Once the fetus is delivered and the cord is clamped, the drug will be administered by the anesthesiologist or anesthetist. Any additional medications required for sedation or pain control during the remainder of the surgery (ketamine, hydromorphone, acetaminophen) will be given, as appropriate for patient comfort. Prior to completion of procedure the patient will receive epidural morphine sulfate per the standard protocols used in MacDonald Women's Hospital. Postoperatively, the patient will receive 3 additional scheduled doses of ketorolac 6 hours apart and intravenous hydromorphone, as needed for pain control.


Criteria:

Inclusion Criteria: - Patients undergoing a scheduled or non-scheduled, non-urgent primary or repeat Cesarean delivery between 37-42 weeks gestational age, - Viable singleton intra-uterine pregnancy, - Patients undergoing a scheduled or unscheduled, non-emergent/non-urgent Cesarean delivery for placenta previa or vasa previa, - Intra-operative epidural or combined spinal epidural, - Patients must be 18 years or older as well as willing and able to provide informed consent. Exclusion Criteria: - Patients younger than 18 years, - Patients unable or unwilling to provide informed consent, - Patients undergoing urgent or emergent Cesarean, - Multi-fetal gestations (>1 intrauterine pregnancy), - Patients undergoing Cesarean delivery for reasons related to bleeding such as placental abruption or actively bleeding placenta previa or vasa previa, - Patients with a contraindication to NSAID use eg: allergy, chronic renal disease, - Patients with acute or chronic platelet dysfunction (e.g.: idiopathic thrombocytopenic purpura, HELLP syndrome), - Patients with gestational thrombocytopenia and platelets <100k, - Patients with history of peptic ulcer disease, - Patients with inherited or acquired coagulopathies or bleeding disorder, (disseminated intravascular coagulopathy, hemophilia), - Patients with suspected or proven placenta accreta, increta or percreta, - Estimated blood loss greater than 1000 mL prior to cord-clamp, - Inability to receive epidural morphine, - Patients with a diagnosed chronic pain disorder on chronic adjunct or opioid analgesia, - Use of general anesthesia during procedure.


NCT ID:

NCT02509312


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States

John J Kowalczyk, MD
Phone: 216-844-8551
Email: john.kowalczyk@uhhospitals.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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