Clinical trial NCT05248984: Dosing of Ketorolac Impacts Post-cesarean paiN manaGemenet (KING)
Official title: Dosing of Ketorolac Impacts Post-cesarean paiN manaGemenet (KING): A Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Cesarean Pain
Keywords: Postoperative pain
Cesarean
Ketorolac
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
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.

Brief 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.

Eligibility criteria: 1. Inclusion criteria:

   * Pregnant individuals aged 18-45 with a viable single or twin intrauterine pregnancy
   * Cesarean section as the delivery mode
   * Regional anesthesia (Spinal, Epidural, Combined Spinal Epidural)
2. Exclusion criteria:

   * Known allergy or adverse reaction to Non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or ketorolac
   * Patients with peptic ulcer disease, preexisting kidney or liver disease
   * Hemodynamically unstable due to hemorrhage
   * Acute or chronic pain disorder
   * Physician/provider or patient refusal
   * Estimated blood loss \> 2000 mL
   * General anesthesia
   * Opioid use disorder
   * Emergent Cesarean delivery
   * Coagulation disorders
   * Active asthma
   * Patients weighing \<50 kg

Primary outcomes:
measure: Comparing the morphine milligram equivalents (MME) use in the first 24 hours. postoperatively after cesarean section
timeFrame: After cesarean surgery up to 24 hours.
Secondary outcomes:
measure: Comparing the morphine milligram equivalents (MME) use during hospital stay.
timeFrame: After cesarean surgery during hospital stay up to 2-3 days.
measure: Comparing patient reported pain score assessment.
timeFrame: After cesarean surgery up to 24 hours.
measure: Comparing the time to first administration of opioid pain medication postoperatively.
timeFrame: After cesarean surgery up to 2-3 days.
measure: Evaluating adverse maternal outcomes.
timeFrame: After cesarean surgery during hospital stay up to 2-3 days.
measure: Evaluating type of skin incision.
timeFrame: After cesarean surgery during hospital stay up to 2-3 days.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
state: Ohio
Study officials:
References: