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Nasal Fentanyl And Renal Colic

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: NCT01339624
Recruitment Status : Completed
First Posted : April 20, 2011
Last Update Posted : April 20, 2011
Sponsor:
Information provided by:
Valduce Hospital

Brief Summary:
The purpose of this study is to determine whether nasal fentanyl is effective in the treatment of renal colic in adults in emergency department.

Condition or disease Intervention/treatment Phase
Acute Renal Colic Drug: FENTANYL Drug: Ketorolac Tromethamine AND morphine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: NASAL FENTANYL, Drug: FENTANYL
FENTANYL CITRATE, NASAL, 3 GAMMA/KG

Active Comparator: KETOROLAC + MORPHINE Drug: Ketorolac Tromethamine AND morphine
morphine 5 MG diluted in saline solution 100 ml followed by 2-ml ampoule of ketorolac 30 MG in saline solution 100 ml was infused:




Primary Outcome Measures :
  1. Change in visual analogue scale pain intensity score [ Time Frame: 30 and 60 minutes ]
    This measure was obtained using a 10-cm with marked numbers visual analog scale (VAS score).


Secondary Outcome Measures :
  1. Use of rescue therapy at 30 minutes [ Time Frame: 30 MINUTES ]
  2. The occurrence of adverse events [ Time Frame: 60 minutes ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patients were adults aged 18 to 65 years, presenting in ED with classical clinical symptoms of renal colic (sudden monolateral flank pain with inguinal irradiation) with a 10-cm visual analog scale (VAS) greater than or equal to 7

Exclusion Criteria:

  • Were analgesia within 6 hours of arrival
  • Allergy to opiates and NSAIDs
  • Opiates abuse, known or suspected abdominal aortic dissection or aneurism,
  • Presence of peritonitis
  • Hemodynamic instability
  • Pregnancy, breastfeeding, anticoagulant therapy.
  • Patients with known renal, pulmonary, cardiac or hepatic failure, as well as those with renal transplantation, were also excluded.

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): NCT01339624


Locations
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Italy
Valduce Hospital
Como, Italy, 22100
Sponsors and Collaborators
Valduce Hospital
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Responsible Party: MASSIMILIANO ETTERI, VALDUCE HOSPITAL
ClinicalTrials.gov Identifier: NCT01339624    
Other Study ID Numbers: NASAL FENTANYL-01
First Posted: April 20, 2011    Key Record Dates
Last Update Posted: April 20, 2011
Last Verified: September 2009
Keywords provided by Valduce Hospital:
analgesia
renal colic
ketorolac
nasal fentanyl
morphine.
treatment of acute renal colic
Additional relevant MeSH terms:
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Colic
Renal Colic
Infant, Newborn, Diseases
Pain
Neurologic Manifestations
Ketorolac
Ketorolac Tromethamine
Fentanyl
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action