Nasal Fentanyl And Renal Colic

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

Study Overview

• Status: Completed
• Conditions: Acute Renal Colic
• Intervention / Treatment: Drug: FENTANYL; Drug: Ketorolac Tromethamine AND morphine

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Como, Italy, 22100
    • Valduce Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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:

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Use of rescue therapy at 30 minutes	30 MINUTES
The occurrence of adverse events	60 minutes

Collaborators and Investigators

• Sponsor: Valduce Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: April 15, 2011
• First Submitted That Met QC Criteria: April 19, 2011
• First Posted (Estimate): April 20, 2011

Study Record Updates

• Last Update Posted (Estimate): April 20, 2011
• Last Update Submitted That Met QC Criteria: April 19, 2011
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: analgesia; ketorolac; renal colic; nasal fentanyl; morphine.; treatment of acute renal colic
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Infant, Newborn, Diseases; Renal Colic; Colic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl; Ketorolac; Morphine; Ketorolac Tromethamine
• Other Study ID Numbers: NASAL FENTANYL-01