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Nasal Fentanyl And Renal Colic

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01339624
Enrollment
65
Registered
2011-04-20
Start date
2009-01-31
Completion date
2009-09-30
Last updated
2011-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Colic

Keywords

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

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.

Interventions

DRUGFENTANYL

FENTANYL CITRATE, NASAL, 3 GAMMA/KG

DRUGKetorolac 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:

Sponsors

Valduce Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in visual analogue scale pain intensity score30 and 60 minutesThis measure was obtained using a 10-cm with marked numbers visual analog scale (VAS score).

Secondary

MeasureTime frame
Use of rescue therapy at 30 minutes30 MINUTES
The occurrence of adverse events60 minutes

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026