Dosing of Ketorolac Impacts Post-cesarean paiN manaGemenet (KING)
Condition: Post Cesarean Pain
Study type: Observational

Summary: 
      This is a randomized controlled single blinded trial to compare the morphine milligram
      equivalents (MME) use in the first 24 hours postoperatively after cesarean section in
      patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous
      ketorolac in the operating room after the end of surgery.
    

Detailed description: 
      Administration of a dose of ketorolac for postoperative pain management at end of cesarean is
      routine practice at our institution.

      This is a randomized controlled single blinded trial at The Ohio State University comparing a
      single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating
      room immediately after cesarean section.

      Potential study participants will be identified at the time of admission to Labor and
      Delivery unit. Inclusion criteria must be met, namely patient's age, mode of delivery via
      cesarean section. The decision for mode of delivery will be at the discretion of the primary
      obstetrics (OB) provider. Indications for cesarean delivery would be: scheduled cesarean due
      to history of previous uterine surgery including prior cesarean section, failed induction of
      labor, arrest of second stage of labor, non-reassuring fetal status.

      Patients will be approached for consent and enrollment when decision is made to proceed for
      cesarean section by their primary provider. Patients with allergy to Non-steroidal
      anti-inflammatory drugs (NSAIDs), history of opioid use disorder, chronic pain disorders, or
      undergoing an emergent Cesarean section, will be excluded from the study.

      Once the decision has been made by the primary obstetrics (OB) provider to proceed with
      cesarean delivery, participants will be randomized in to one of two groups:

        -  Single dose of IV Ketorolac 30mg Vs.

        -  Single dose of IV Ketorolac 60mg

      The intervention and primary outcome will take place over the span of 24 hour post-cesarean.
      Once enrolled and randomized, patients will be given either 60 mg or 30 mg of IV ketorolac at
      the end of the procedure. All other obstetric care will be at the discretion of the primary
      provider, including but not limited to pain management postoperatively. Analysis will be by
      intent to treat. The secondary outcomes will be collected during the hospital stay until
      discharge.
    

Intervention name(s): Ketorolac
Intervention type(s): Drug
Intervention description(s): Once the decision has been made by the primary obstetrics (OB) provider to proceed with cesarean delivery, participants will be randomized in to one of two groups:
Single dose of intravenous (IV) Ketorolac 30mg Vs.
Single dose of intravenous (IV) Ketorolac 60mg
Intervention MeSH terms: Ketorolac
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant individuals undergoing a cesarean section at The Ohio State University Wexner
        Medical Center.
      
Keywords: Postoperative pain; Cesarean; Ketorolac