Back to resultsNasal Fentanyl And Renal Colic
Primary Purpose
Acute Renal Colic
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
FENTANYL
Ketorolac Tromethamine AND morphine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Renal Colic focused on measuring analgesia, renal colic, ketorolac, nasal fentanyl, morphine., treatment of acute renal colic
Eligibility 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.
Sites / Locations
- Valduce Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
NASAL FENTANYL,
KETOROLAC + MORPHINE
Arm Description
Outcomes
Primary Outcome Measures
Change in visual analogue scale pain intensity score
This measure was obtained using a 10-cm with marked numbers visual analog scale (VAS score).
Secondary Outcome Measures
Use of rescue therapy at 30 minutes
The occurrence of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01339624
Brief Title
Nasal Fentanyl And Renal Colic
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Valduce Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Renal Colic
Keywords
analgesia, renal colic, ketorolac, nasal fentanyl, morphine., treatment of acute renal colic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NASAL FENTANYL,
Arm Type
Active Comparator
Arm Title
KETOROLAC + MORPHINE
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
FENTANYL
Intervention Description
FENTANYL CITRATE, NASAL, 3 GAMMA/KG
Intervention Type
Drug
Intervention Name(s)
Ketorolac Tromethamine AND morphine
Intervention Description
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 Measure Information:
Title
Change in visual analogue scale pain intensity score
Description
This measure was obtained using a 10-cm with marked numbers visual analog scale (VAS score).
Time Frame
30 and 60 minutes
Secondary Outcome Measure Information:
Title
Use of rescue therapy at 30 minutes
Time Frame
30 MINUTES
Title
The occurrence of adverse events
Time Frame
60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Valduce Hospital
City
Como
ZIP/Postal Code
22100
Country
Italy
12. IPD Sharing Statement
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Nasal Fentanyl And Renal Colic
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