Prospective Effect of Intravenous Ketorolac on Opioid Use and Complications Following Cesarean Delivery

• Status: Unknown status
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Treatments: Analgesics; Analgesics, Opioid; Hydromorphone; Ketorolac; Ketorolac Tromethamine; Morphine

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.