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Comparison of IV 10, 20, and 30mg for Renal Colic Pain in the ED

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ClinicalTrials.gov Identifier: NCT03665753
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Hadi Mirfazaelian, Tehran University of Medical Sciences

Brief Summary:
Hypothesis: Intravenous administration of Ketorolac 10 mg and 20 mg is as effective as 30 mg in treating renal colic pain in patients presenting to the emergency department

Condition or disease Intervention/treatment Phase
Pain Renal Colic Drug: Ketorolac Early Phase 1

Detailed Description:
Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that is widely used in the Emergency Department (ED). Because of the Ketorolac significant analgesic potency, it is usually used for moderate-to-severe pain. However, ketorolac has several side effects, of which gastrointestinal hemorrhage is most concerning. "Analgesic ceiling" is defined as the dose beyond which no additional analgesia can be achieved and on the other hand, more side effects might be encountered. Several studies suggested 10 mg as analgesic ceiling. Despite this, many recommendations are still advocating several folds higher doses (e.g. 30, 60 mg).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Dose escalation study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Intravenous Ketorolac 10, 20, and 30mg for Treating Renal Colic Pain in the Emergency Department: A Randomized Controlled Trial
Actual Study Start Date : August 5, 2017
Estimated Primary Completion Date : September 15, 2019
Estimated Study Completion Date : September 15, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ketorolac

Arm Intervention/treatment
Experimental: Ketorolac 10mg
Subjects will be administered 10 mg of Ketorolac.
Drug: Ketorolac
Subject will receive 10, 20, and 30mg of Ketorolac.

Experimental: Ketorolac 20mg
Subjects will be administered 20 mg of Ketorolac
Drug: Ketorolac
Subject will receive 10, 20, and 30mg of Ketorolac.

Experimental: Ketorolac 30mg
As a part of standard care, subjects will be administered 30 mg of Ketorolac.
Drug: Ketorolac
Subject will receive 10, 20, and 30mg of Ketorolac.




Primary Outcome Measures :
  1. Pain assessed with visual analogue scale (VAS) [ Time Frame: 30 Minutes ]
    The visual analogue scale (VAS) will be used for the study. The VAS ranges from 0 (no pain) to 100 (very severe pain). The higher the pain scores the higher the pain severity.


Secondary Outcome Measures :
  1. Pain assessed with visual analogue scale (VAS) [ Time Frame: 15 Minutes ]
    The visual analogue scale (VAS) will be used for the study. The VAS ranges from 0 (no pain) to 100 (very severe pain). The higher the pain scores the higher the pain severity.

  2. Pain assessed with visual analogue scale (VAS) [ Time Frame: 45 Minutes ]
    The visual analogue scale (VAS) will be used for the study. The VAS ranges from 0 (no pain) to 100 (very severe pain). The higher the pain scores the higher the pain severity.

  3. Pain assessed with visual analogue scale (VAS) [ Time Frame: 60 Minutes ]
    The visual analogue scale (VAS) will be used for the study. The VAS ranges from 0 (no pain) to 100 (very severe pain). The higher the pain scores the higher the pain severity.

  4. Adverse Effects [ Time Frame: 60 Minutes ]
    Dizziness (Adverse Effect), Nausea (Adverse Effect), Vomiting (Adverse Effect), headache (Adverse Effect)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Severe flank and abdominal pain which pertains to renal colic according to emergency physician's gestalt

Exclusion Criteria:

  • Age >65
  • Active Peptic Ulcer disease
  • Acute Gastrointestinal Hemorrhage
  • Known History of Renal or Hepatic insufficiency
  • History of allergies to NSAIDs

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): NCT03665753


Contacts
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Contact: Hadi Mirfazaelian, M.D. 0982166904848 h-mirfazaelian@sina.tums.ac.ir
Contact: Maryam Bahreini, M.D. 098216119 ext 2240 mbahreini@yahoo.com

Locations
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Iran, Islamic Republic of
IKCH Recruiting
Tehran, Iran, Islamic Republic of
Contact: Hadi Mirfazaelian, MD    +982166904848    h-mirfazaelian@sina.tums.ac.ir   
Sponsors and Collaborators
Tehran University of Medical Sciences

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Responsible Party: Hadi Mirfazaelian, Assistant Professor of Emergency Medicine, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03665753     History of Changes
Other Study ID Numbers: 9521307004
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colic
Renal Colic
Infant, Newborn, Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
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