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Completed

NCT Number: NCT01339624

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.

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Key information

Conditions

Acute Renal Colic Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Renal Colic Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Valduce Hospital

Como, 22100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fentanyl

Drug

FENTANYL CITRATE, NASAL, 3 GAMMA/KG

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:

Primary outcomes

  1. Change in visual analogue scale pain intensity score

    Time frame: 30 and 60 minutes

    This measure was obtained using a 10-cm with marked numbers visual analog scale (VAS score).

Secondary outcomes

  1. Use of rescue therapy at 30 minutes

    Time frame: 30 MINUTES

  2. The occurrence of adverse events

    Time frame: 60 minutes

Sponsors and collaborators

Lead sponsor

Valduce Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 20, 2011
Registry last updated
Apr 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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