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CompletedNCT01339624Updated Apr 20, 2011

Nasal Fentanyl And Renal Colic

An interventional study of FENTANYL and Ketorolac Tromethamine AND morphine in Acute Renal Colic, sponsored by Valduce Hospital. Completed at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-04-20.

Sponsored by Valduce Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Renal Colic

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Keywords

  • analgesia
  • renal colic
  • ketorolac
  • nasal fentanyl
  • morphine.
  • treatment of acute renal colic
03

In context

Colic

148 studies on the registry are indexed under Colic; 21 are open to participants now.

This study's enrollment of 65 is below the median of 88 across 122 interventional studies indexed under Colic.

Browse Colic studies →

Lead sponsor

Valduce Hospital is the lead sponsor of 26 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
65 participants (actual)

Study arms

  • Active comparator
    NASAL FENTANYL,

    Drug: FENTANYL

  • Active comparator
    KETOROLAC + MORPHINE

    Drug: Ketorolac Tromethamine AND morphine

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:

06

What researchers measure

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).

    Time frame: 30 and 60 minutes

Secondary outcomes

  1. Use of rescue therapy at 30 minutes

    Time frame: 30 MINUTES

  2. The occurrence of adverse events

    Time frame: 60 minutes

07

Study locations

1 site
  • Valduce Hospital
    Como, 22100, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01339624
Lead sponsor
Valduce Hospital
First posted
Apr 20, 2011
Start date
Jan 2009
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Apr 20, 2011
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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