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Trial record 35 of 463 for:    KETOROLAC

Morphine Versus Ketorolac in Renal Colic

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ClinicalTrials.gov Identifier: NCT02782273
Recruitment Status : Unknown
Verified May 2016 by Loredana Ghinea, Bucharest Emergency Hospital.
Recruitment status was:  Not yet recruiting
First Posted : May 25, 2016
Last Update Posted : May 25, 2016
Sponsor:
Information provided by (Responsible Party):
Loredana Ghinea, Bucharest Emergency Hospital

Brief Summary:
The study is prospective, double blinded, randomised controlled and has the purpose to compare the analgesic effects of ketorolac or morphine intravenous in renal colic.

Condition or disease Intervention/treatment Phase
Renal Colic Drug: Ketorolac Drug: Morphine Phase 4

Detailed Description:

The study will take place in the Emergency Department of the Clinical Emergency Hospital Bucharest and will compare the analgesic effects of ketorolac tromethamine against morphine in renal colic.

The patients will be randomised to receive either ketorolac 30 mg intravenous (diluted in 20 ml of 0,9% saline) or morphine 0,1 mg/kg weight intravenous. A scale of 1-10 will be used for measuring the pain, and the effects of the treatment will be evaluated at 15 minutes and 30 minutes from the administration of the drugs. After 30 minutes if there is no significant reduction of the pain a rescue therapy will be used : chlorhydrate drotaverine 40 mg, xilocaine 100 mg, both diluted in 100 ml saline and the other medication not used from the study (morphine or ketorolac tromethamine).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Analgesic Effects of Morphine Versus Ketorolac in Renal Colic
Study Start Date : May 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ketorolac
The patients randomised to this arm they will receive 30 mg intravenous ketorolac.
Drug: Morphine
The patients randomised to this arm they will receive 0,1 mg/kg intravenous morphine.

Active Comparator: Morphine
The patients randomised to this arm they will receive 0,1 mg/kg intravenous morphine.
Drug: Ketorolac
The patients randomised to this arm they will receive 30 mg intravenous ketorolac.




Primary Outcome Measures :
  1. Reducing the grade of pain [ Time Frame: 15 minutes, 30 minutes ]
    To see the reducing of the pain on a scale 1-10 at two time points


Secondary Outcome Measures :
  1. Time of staying in emergency department [ Time Frame: 30 minutes, 1 hour, 2 hours ]
  2. The necessity of urology consult - interventional measures [ Time Frame: 7 days ]
    The patients will be called after 7 days to see if they needed urology consult and urological intervention

  3. The cost of each treatment [ Time Frame: 1 hour ]
    To evaluate the costs of treatment of each type of drug and/or rescue therapy

  4. The necessity to use rescue therapy - pain > 5 grade [ Time Frame: 30 minutes ]
    30 minutes from presentation in the ED - if the pain is still > 5 on a 1-10 scale

  5. Side effects of each treatment [ Time Frame: 30 minutes ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of renal colic
  • grade 5 pain on a 1-10 visual pain scale

Exclusion Criteria:

  • contraindications of ketorolac or opioids
  • pregnancy
  • allergies to ketorolac or opioids
  • refusal of 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): NCT02782273


Contacts
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Contact: Dan Marinescu, MD 0040741020848 danvmarinescu@gmail.com
Contact: Loredana Ghinea, MD 0040740694284 loredana.ghinea@gmail.com

Sponsors and Collaborators
Loredana Ghinea
Investigators
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Principal Investigator: Dan Marinescu, MD Clinical Emergency Hospital Bucharest

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Responsible Party: Loredana Ghinea, Medical Doctor, Bucharest Emergency Hospital
ClinicalTrials.gov Identifier: NCT02782273     History of Changes
Other Study ID Numbers: 1-4627
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: May 25, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Loredana Ghinea, Bucharest Emergency Hospital:
ketorolac
pain relieve
morphine

Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Colic
Renal Colic
Infant, Newborn, Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
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