IV Ketorolac on Platelet Function Post-Cesarean Delivery

NCT03805607 | Completed Phase 4 FDA Drug

• 1 other identifier: 2018P000625
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analgesia, Obstetrical; Coagulation Defect; Postpartum; Nonsteroidals (NSAIDs)Toxicity; Postpartum Hemorrhage; Postoperative Pain; Ketorolac Adverse Reaction; Blood Loss, Postoperative

Keywords

Cesarean Section Complications; Blood Loss, Surgical; Coagulation Defect; Postpartum; Nonsteroidals (NSAIDs)Toxicity; Postpartum Hemorrhage; Ketorolac; Cesarean Delivery; Platelet Function; Cyclooxygenase Inhibitors/administration & dosage; Female; Humans; Ketorolac/administration & dosage; Pain, Postoperative/drug therapy; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Platelet Aggregometry Light Transmission

  Platelet Aggregometry uses measurements platelet rich blood or serum samples and activating agents to analyze the percent change in light transmission as a marker of platelet aggregation.

  15 minutes after dosing of placebo or ketorolac

Secondary Outcomes (4)

• Thromboelastogram parameters including Reaction time (R)

  15 minutes after dosing of placebo or ketorolac

• Thromboelastogram parameters including Angle (alpha)

  15 minutes after dosing of placebo or ketorolac

• Thromboelastogram parameters including Kinetics (K)

  15 minutes after dosing of placebo or ketorolac

• Thromboelastogram parameters including Maximum Amplitude (MA)

  15 minutes after dosing of placebo or ketorolac

Study Arms (2)

Placebo

PLACEBO COMPARATOR

1 ml of normal saline

Drug: Placebos

Ketorolac

EXPERIMENTAL

30 mg of ketorolac in 1 ml

Drug: Ketorolac Tromethamine 30 MG/ML

Interventions

Ketorolac Tromethamine 30 MG/ML DRUG

Ketorolac 30 mg

Also known as: ketorolac, Ketorolac Tromethamine, Ketorolac Injectable Solution

Ketorolac

Placebos DRUG

Normal Saline

Also known as: Placebo, Normal Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant
• Undergoing routine, scheduled cesarean section
• Gestation \>37 weeks
• Singleton gestation
• 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

You may not qualify if:

• Pre-eclampsia with severe features or HELLP
• Allergy to NSAIDs
• Pre-existing bleeding disorder
• Other major risk factor for postpartum hemorrhage (placenta accreta, large uterine fibroid)
• Chronic kidney disease
• Plt count less than 100k
• Gastric ulcer or gastric bleeding
• Pre-existing uterine bleeding or disseminated intravascular coagulation
• Patient or Obstetrician refusal

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Society for Obstetric Anesthesia and Perinatology: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (7)

• Blackburn A, Stevens JD, Wheatley RG, Madej TH, Hunter D. Balanced analgesia with intravenous ketorolac and patient-controlled morphine following lower abdominal surgery. J Clin Anesth. 1995 Mar;7(2):103-8. doi: 10.1016/0952-8180(94)00040-b.

  PMID: 7598916 BACKGROUND

• Diemunsch P, Alt M, Diemunsch AM, Treisser A. Post cesarean analgesia with ketorolac tromethamine and uterine atonia. Eur J Obstet Gynecol Reprod Biol. 1997 Apr;72(2):205-6. doi: 10.1016/s0301-2115(96)02682-6. No abstract available.

  PMID: 9134403 BACKGROUND

• Pavy TJ, Paech MJ, Evans SF. The effect of intravenous ketorolac on opioid requirement and pain after cesarean delivery. Anesth Analg. 2001 Apr;92(4):1010-4. doi: 10.1097/00000539-200104000-00038.

  PMID: 11273941 BACKGROUND

• Lowder JL, Shackelford DP, Holbert D, Beste TM. A randomized, controlled trial to compare ketorolac tromethamine versus placebo after cesarean section to reduce pain and narcotic usage. Am J Obstet Gynecol. 2003 Dec;189(6):1559-62; discussion 1562. doi: 10.1016/j.ajog.2003.08.014.

  PMID: 14710063 BACKGROUND

• El-Tahan MR, Warda OM, Yasseen AM, Attallah MM, Matter MK. A randomized study of the effects of preoperative ketorolac on general anaesthesia for caesarean section. Int J Obstet Anesth. 2007 Jul;16(3):214-20. doi: 10.1016/j.ijoa.2007.01.012. Epub 2007 Apr 24.

  PMID: 17459695 BACKGROUND

• Elhakim M, Fathy A, Amine H, Saeed A, Mekawy M. Effect of i.v. tenoxicam during caesarean delivery on platelet activity. Acta Anaesthesiol Scand. 2000 May;44(5):555-9. doi: 10.1034/j.1399-6576.2000.00512.x.

  PMID: 10786742 BACKGROUND

• Gobble RM, Hoang HLT, Kachniarz B, Orgill DP. Ketorolac does not increase perioperative bleeding: a meta-analysis of randomized controlled trials. Plast Reconstr Surg. 2014 Mar;133(3):741-755. doi: 10.1097/01.prs.0000438459.60474.b5.

  PMID: 24572864 BACKGROUND

MeSH Terms

Conditions

Agnosia; Hemostatic Disorders; Postpartum Hemorrhage; Pain, Postoperative; Postoperative Hemorrhage; Blood Loss, Surgical; Pain

Interventions

Ketorolac Tromethamine; Ketorolac; Saline Solution

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Postoperative Complications; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo (normal saline) or ketorolac in syringe prepared by the investigational pharmacy with study patient number and blinding key maintained by investigational pharmacy until time of unblinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anaesthesia

Model Details: Randomized Placebo-Controlled Trial

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 15, 2019
• Study Start: January 18, 2021
• Primary Completion: February 3, 2022
• Study Completion: March 30, 2024
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)