Nasal Fentanyl And Renal Colic

NCT01339624 | Completed

• 1 other identifier: NASAL FENTANYL-01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Renal Colic

Keywords

analgesia; renal colic; ketorolac; nasal fentanyl; morphine.; treatment of acute renal colic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Use of rescue therapy at 30 minutes

  30 MINUTES

• The occurrence of adverse events

  60 minutes

Study Arms (2)

NASAL FENTANYL,

ACTIVE COMPARATOR

Drug: FENTANYL

KETOROLAC + MORPHINE

ACTIVE COMPARATOR

Drug: Ketorolac Tromethamine AND morphine

Interventions

FENTANYL DRUG

FENTANYL CITRATE, NASAL, 3 GAMMA/KG

NASAL FENTANYL,

Ketorolac Tromethamine AND morphine DRUG

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:

KETOROLAC + MORPHINE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Valduce Hospital: lead

Study Sites (1)

Valduce Hospital

Como, 22100, Italy

Location

MeSH Terms

Conditions

Renal Colic; Agnosia

Interventions

Fentanyl; Ketorolac Tromethamine; Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 20, 2011
• Study Start: January 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: April 20, 2011

Record last verified: 2009-09

Locations

IT (1)