Nasal Fentanyl And Renal Colic

Acute Renal Colic Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01339624
• Other study ID #: NASAL FENTANYL-01
• Status: Completed
• Phase: N/A
• First received: April 15, 2011
• Last updated: April 19, 2011
• Start date: January 2009
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: Valduce Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Renal Colic
• Colic
• Renal Colic

Intervention

Drug:
• FENTANYL
FENTANYL CITRATE, NASAL, 3 GAMMA/KG
• 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:

Locations

Country	Name	City	State
Italy	Valduce Hospital	Como

Sponsors (1)

Lead Sponsor	Collaborator
Valduce Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Use of rescue therapy at 30 minutes		30 MINUTES	No
Secondary	The occurrence of adverse events		60 minutes	Yes