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Trial record 17 of 463 for:    KETOROLAC

Ketorolac Use in Pediatric Patients Undergoing Tonsillectomy

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ClinicalTrials.gov Identifier: NCT03453541
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Farzana Afroze, Albany Medical College

Brief Summary:
This prospective, randomized, double blinded study is designed to compare the bleeding rates of ketorolac vs. placebo when used for post tonsillectomy pain control in pediatric patients ages 2-18.

Condition or disease Intervention/treatment Phase
Analgesic Adverse Reaction Drug: Ketorolac Tromethamine Drug: 0.9% Normal Saline Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: CRNAs, PACU nurses, and participants are all blinded
Primary Purpose: Treatment
Official Title: A Randomized, Double-blinded, Placebo-controlled Study of Ketorolac Use in Pediatric Patients Undergoing Tonsillectomy
Actual Study Start Date : November 21, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
Experimental: Ketorolac Tromethamine
This group receives Ketorolac Tromethamine 0.5 mg/kg IV up to a maximum dose of 30mg, in the form of Ketorolac Tromethamine solution for IV/IM use 30mg/ml single dose vial at the completion of the tonsillectomy in the operating room.
Drug: Ketorolac Tromethamine
Ketorolac Tromethamine 0.5 mg/kg IV up to a maximum dose of 30mg, in the form of Ketorolac Tromethamine solution for IV/IM use 30mg/ml single dose vial at the completion of the tonsillectomy in the operating room.
Other Name: Toradol

Placebo Comparator: 0.9% Normal Saline
This group will receive 0.9% Normal Saline solution 1ml/60kg up to 1ml IV bolus (an equivalent volume as per kg Ketorolac Tromethamine dose) at the completion of the tonsillectomy in the operating room.
Drug: 0.9% Normal Saline
0.9 % Normal saline 1ml/60kg up to a maximum dose of 1ml IV bolus (an equivalent volume as per kg Ketorolac Trimethamine dose) at the completion of the tonsillectomy in the operating room.
Other Name: 0.9% Sodium Chloride




Primary Outcome Measures :
  1. Rebleeding rate requiring operative intervention [ Time Frame: 2 weeks post-operative ]
    Rebleeding rate requiring operative intervention measured by recording either yes or no the patient did or did not returned to the OR for bleeding related to recent tonsillectomy. Requiring operative intervention would be a worse outcome than not requiring operative intervention.


Secondary Outcome Measures :
  1. PACU length of stay [ Time Frame: Immediately after operation ]
    PACU length of stay in minutes from admission to discharge. The longer the length of PACU stay the worse the outcome.

  2. Post-operative opioid dosage [ Time Frame: Immediately after operation ]
    Post- operative opioid requirement in mg of Morphine/ Morphine equivalent. The greater the amount of opioid used the worse the outcome.

  3. Post-operative pain score [ Time Frame: Immediately after operation ]
    Pain scores ranging from 0 to 5 will be collected using the Visual Analogue Pain. scale. A score of 0 indicates no pain and a score of 5 indicates unbearable pain. The greater the pain score would indicate a worse outcome.

  4. Presence of post-operative nausea/vomiting [ Time Frame: Immediately after operation ]
    The presence of post operative nausea or vomiting while in the PACA measured by either yes or no. The presence of pots-operative nausea or vomiting would indicate a worse outcome.

  5. Number of emergency room visits/admissions [ Time Frame: 2 weeks post-operative ]
    The number of actual emergency room visits by the patient measured numerically from 1 to infinity. The greater the number of emergency room visits would indicate a worse outcome.



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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-ASA physical status I to III, age of 2 years to 18 years old (inclusive) scheduled for elective tonsillectomy with or without adenoidectomy.

Exclusion Criteria:

-Exclusion criteria are: allergy to any nonsteroidal anti-inflammatory medications, bleeding disorders, history of gastrointestinal bleeding, renal impairment, severe asthma, cardiac/hepatic disease, use of anticoagulation, recent NSAID use (within last 72 hours) or any other medical problem that in the opinion of investigator would interfere with study participation.


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): NCT03453541


Contacts
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Contact: Farzana Afroze, MD 518-262-3125 AfrozeF@amc.edu
Contact: Jason mouzakas, MD 518-262-4300

Locations
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United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Farzana Afroze, MD    518-262-3125    AfrozeF@amc.edu   
Sub-Investigator: Eric P Zhou, MD         
Sub-Investigator: Carolyn DeBiase, MD         
Sub-Investigator: Melissa Ehlers, MD         
Sub-Investigator: Sakina Rangwala, MD         
Sub-Investigator: Jason Mouzakes, MD         
Sub-Investigator: Patrick Savery, DO         
Sub-Investigator: Anica Crnkovic, MD         
Sub-Investigator: Helena Oechsner, MD         
Sub-Investigator: Yarnell LaFortune, MD         
Sub-Investigator: Igor Galay, MD         
Sub-Investigator: : Pragnyadipta Mishra, MBBS         
Sponsors and Collaborators
Albany Medical College
Investigators
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Principal Investigator: Farzana Afroze, MD Albany Medical College

Publications:
Ketorolac., Drug Facts and Comparisons 4.0 (online). I. Wolters Kluwer Health, Editor. 2011.
Ketorolac. National Cancer Institute Drug Dictionary.
26. Ketorolac: Peds Dosing. 2017: Epocrates.
27. Ketorolac Dosage. Drugs.com.

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Responsible Party: Farzana Afroze, Assistant Professor of Anesthesiology, Albany Medical College
ClinicalTrials.gov Identifier: NCT03453541     History of Changes
Other Study ID Numbers: 4923
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
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

Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action