Prospective Effect of Intravenous Ketorolac on Opioid Use, EBL and Complications Following Cesarean Delivery
Condition: Analgesia, Obstetrical; Postpartum Hemorrhage; Opioid Use; Nonsteroidals (NSAIDs)Toxicity; Coagulation Defect; Postpartum; Postoperative Pain; Ketorolac Adverse Reaction; Blood Loss, Postoperative
MeSH terms: Postpartum Hemorrhage; Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage; Postoperative Hemorrhage
Intervention: Ketorolac; Placebo
Intervention description: Patients in the experimental arm will receive ketorolac 30 mg in 1 ml at the time of cord clamp and then for 3 more doses every 6 hours.; Patients in the control arm will receive normal saline 1 ml at the time of cord clamp and then for 3 more doses every 6 hours.
Intervention MeSH terms: Ketorolac
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Placebo (normal saline) or ketorolac in syringe prepared by the investigational pharmacy with study kit number and blinding key maintained by investigational pharmacy until time of unblinding.
Enrollment: 70.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Analgesia, Obstetrical; Blood Loss, Surgical; Analgesics, Opioid/administration & dosage; Cyclooxygenase Inhibitors/administration & dosage; Cesarean Delivery; Female; Humans; Ketorolac/administration & dosage; Hydromorphone/administration & dosage; Pain, Postoperative/drug therapy; Pregnancy; Morphine/administration & dosage; Cesarean Section Complications; Ketorolac

Summary:

      In this randomized, double-blind control trial to evaluate the effect of ketorolac given at
      the time of cord clamp has on estimated blood loss and postcesarean 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 three additional doses every 6 hours
      (total 4 doses/24 hours). Those in the placebo group will receive normal saline during those
      time periods. Our primary outcome is to assess whether intra-operative ketorolac increases
      the estimated blood loss during Cesarean delivery.
    

Eligibility 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,

          -  Neuraxial anesthesia with combined spinal-epidural placed for surgery,

          -  Patients must be 18 years or older as well as willing and able to provide informed
             consent.

        Exclusion Criteria:

          -  Patients unable or unwilling to provide informed consent,

          -  Urgent or emergent Cesarean delivery

          -  Multiple fetal gestations (>1 intrauterine pregnancy),

          -  Cesarean delivery for bleeding such as placental abruption or actively bleeding
             placenta previa or vasa previa,

          -  Contraindication to NSAID use eg: allergy, chronic renal disease,

          -  Patients with acute or chronic platelet dysfunction (e.g.: idiopathic thrombocytopenic
             purpura, HELLP syndrome),

          -  Platelets <100k,

          -  History of peptic ulcer disease,

          -  Inherited or acquired coagulopathies or bleeding disorder, (disseminated intravascular
             coagulopathy, hemophilia),

          -  Suspected or proven placenta accreta, increta or percreta,

          -  Inability to receive epidural morphine,

          -  Diagnosed chronic pain disorder on chronic adjunct or opioid analgesia,

          -  Use of general anesthesia during procedure.

        Intraoperative exclusion criteria:

        - EBL > 1000 ml prior to cord clamp