Ketorolac for Postoperative Hemorrhage
(KetoPltAgg Trial)

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Beth Israel Deaconess Medical Center

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?Cesarean delivery has become the most common surgical procedure in the US. Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to improve the quality of post-cesarean analgesia and markedly reduce opioid consumption. The effect of NSAIDs on healthy volunteers results in inhibition of platelet aggregation and prolonged bleeding time. However, in the obstetric population, the presence and degree of platelet inhibition after NSAID exposure is less clear. The investigators plan to use Platelet Aggregometry and Thromboelastography (TEG) to evaluate the effect of ketorolac on platelets.

Eligibility Criteria

This trial is for pregnant women over 37 weeks gestation, scheduled for a cesarean section with specific anesthesia. They must not have allergies to NSAIDs, gastric issues, kidney disease, low platelet counts or bleeding disorders. Women with severe pre-eclampsia or risk factors for heavy bleeding post-surgery are excluded.

Inclusion Criteria

Intraoperative anesthesia - 1.5 ml of intrathecal bupivicaine 0.75%, 25mcg of intrathecal fentanyl and 250 mcg of intrathecal morphine via Spinal or Combined Spinal Epidural

Undergoing routine, scheduled cesarean section

Singleton gestation

+2 more

Exclusion Criteria

You are allergic to medications called NSAIDs.

You have a stomach ulcer or have experienced bleeding in your stomach.

Chronic kidney disease

+7 more

Participant Groups

The study tests the effect of Ketorolac Tromethamine on platelet function after cesarean delivery compared to a placebo. It aims to understand if this NSAID affects blood clotting and reduces pain without increasing the risk of hemorrhage in new mothers.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: KetorolacExperimental Treatment1 Intervention

30 mg of ketorolac in 1 ml

Group II: PlaceboPlacebo Group1 Intervention

1 ml of normal saline

Ketorolac Tromethamine is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Toradol for: