CompletedPhase 4

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

United States70 participantsStarted 2016-05

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Estimated Blood Loss (EBL)

Timeframe: Immediately post-op

Trial details

NCT IDNCT02509312

SponsorUniversity Hospitals Cleveland Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10

Results submitted2022-03-02