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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02509312
Recruitment Status : Active, not recruiting
First Posted : July 28, 2015
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
John J. Kowalczyk, University Hospitals Cleveland Medical Center

Brief Summary:
This is a randomized, double blind placebo trial to evaluate whether ketorolac given at the time of cord clamp has any impact on post-partum 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 3 additional doses 6 hours apart (total 4 doses/24 hours). Those in the placebo group will receive placebo medications during those time periods.

Condition or disease Intervention/treatment Phase
Analgesia, Obstetrical Drug: Ketorolac Drug: Epidural Morphine Drug: Hydromorphone Phase 4

Detailed Description:

Screening/Eligibility Visit:

Once the determination for Cesarean delivery has been made, either following admission to labor and delivery or during a prenatal clinic visit, based on clinical indication, the potential participant will be screened and eligibility will be confirmed by a study investigator. A signed, IRB-approved informed consent will be obtained.

Cesarean Delivery:

Cesarean delivery will be performed using the standard procedures established in MacDonald Women's Hospital by an attending physician or chief resident and a junior resident.

Randomization and administration of study medication:

Randomization will be performed by the research pharmacy. Subjects will be randomized in blocks of four. Upon arrival in the OR the anesthesiologist will open an envelope which will demonstrate the number medication the patient will receive based on a blinding key which the pharmacy will possess. At minimum, 6 sets of vials of either placebo or ketorolac will be held in the drug dispensary at any given time. The anesthesiologist or anesthetist will then pull the drug from the dispensary. Once the fetus is delivered and the cord is clamped, the drug will be administered by the anesthesiologist or anesthetist. Any additional medications required for sedation or pain control during the remainder of the surgery (ketamine, hydromorphone, acetaminophen) will be given, as appropriate for patient comfort. Prior to completion of procedure the patient will receive epidural morphine sulfate per the standard protocols used in MacDonald Women's Hospital. Postoperatively, the patient will receive 3 additional scheduled doses of ketorolac 6 hours apart and intravenous hydromorphone, as needed for pain control.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Control Trial of Ketorolac Versus Placebo on Opioid Analgesic Use and Complications Following Cesarean Delivery With Intra-Epidural Morphine
Actual Study Start Date : May 2016
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: Experimental
Patients in this arm will be given ketorolac at cord clamp with standard dose of 30 mg, then 3 additional 30 mg doses every 6 hours
Drug: Ketorolac
Patients in experimental arm will receive ketorolac at time of cord clamp and then for 3 more doses every 6 hours
Other Name: Toradol

Drug: Epidural Morphine
All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Other Name: Duramorph

Drug: Hydromorphone
Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
Other Name: dilaudid

Placebo Comparator: Control
Patients in this arm will be given a placebo medication at cord clamp, and then 3 additional doses of placebo every 6 hours.
Drug: Epidural Morphine
All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Other Name: Duramorph

Drug: Hydromorphone
Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
Other Name: dilaudid




Primary Outcome Measures :
  1. Opioid use [ Time Frame: 24 hours post-partum ]
    Use vs. Non-use and total dose of intravenous hydromorphone administered within first 24 hours after cesarean delivery.

  2. Estimated blood loss (EBL)/Post-operative hemoglobin [ Time Frame: Immediately post-op, 24 hours post-partum ]
    Estimation of blood loss during surgery and hemoglobin measurement on post-operative day #1


Secondary Outcome Measures :
  1. Anti-emetic use [ Time Frame: 0-24 hours ]
    Recording use of ondansetron and promethazine

  2. Blood pressure [ Time Frame: 0-72 hours ]
    Determining whether ketorolac increases blood pressure post-partum, >20 mmHg systolic and >10 mmHg diastolic on at least 2 separate occasions 6 hours apart

  3. Post-partum Hemorrhage (PPH) [ Time Frame: 0-24 hours ]
    Incidence of PPH.

  4. PPH EBL [ Time Frame: 0-24 hours ]
    Estimation of blood loss during if categorized as having PPH.

  5. PPH treatment drugs [ Time Frame: 0-24 hours ]
    Recording of total doses of Methylergonovine, misoprostol, and carboprost.

  6. Post-partum reoperation [ Time Frame: 0-24 hours ]
    Incidence of post-partum reoperation.

  7. Pain score [ Time Frame: 0-24 hours ]
    Recording of patient reported subjective pain score.

  8. Need for opioid side-effect reducing drugs including Diphenhydramine, Nalbuphine and Naloxone. [ Time Frame: 0-24 hours ]
    Recording of total doses of



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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,
  • Intra-operative epidural or combined spinal epidural,
  • Patients must be 18 years or older as well as willing and able to provide informed consent.

Exclusion Criteria:

  • Patients younger than 18 years,
  • Patients unable or unwilling to provide informed consent,
  • Patients undergoing urgent or emergent Cesarean,
  • Multi-fetal gestations (>1 intrauterine pregnancy),
  • Patients undergoing Cesarean delivery for reasons related to bleeding such as placental abruption or actively bleeding placenta previa or vasa previa,
  • Patients with a contraindication to NSAID use eg: allergy, chronic renal disease,
  • Patients with acute or chronic platelet dysfunction (e.g.: idiopathic thrombocytopenic purpura, HELLP syndrome),
  • Patients with gestational thrombocytopenia and platelets <100k,
  • Patients with history of peptic ulcer disease,
  • Patients with inherited or acquired coagulopathies or bleeding disorder, (disseminated intravascular coagulopathy, hemophilia),
  • Patients with suspected or proven placenta accreta, increta or percreta,
  • Estimated blood loss greater than 1000 mL prior to cord-clamp,
  • Inability to receive epidural morphine,
  • Patients with a diagnosed chronic pain disorder on chronic adjunct or opioid analgesia,
  • Use of general anesthesia during procedure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509312


Locations
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United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center

Publications:
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Responsible Party: John J. Kowalczyk, Anesthesiology Fellow Physician, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02509312     History of Changes
Other Study ID Numbers: Ketorolac-1
First Posted: July 28, 2015    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by John J. Kowalczyk, University Hospitals Cleveland Medical Center:
Ketorolac/administration & dosage
Analgesia, Obstetrical
Blood Loss, Surgical
Analgesics, Opioid/administration & dosage
Cyclooxygenase Inhibitors/administration & dosage
Cesarean Section
Female
Humans
Hydromorphone/administration & dosage
Pain, Postoperative/drug therapy
Pregnancy
Morphine/administration & dosage
Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Analgesics, Opioid
Morphine
Hydromorphone
Analgesics
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action