Nasal Fentanyl And Renal Colic

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Acute Renal Colic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NASAL FENTANYL,

Group Type ACTIVE_COMPARATOR

FENTANYL

Intervention Type DRUG

FENTANYL CITRATE, NASAL, 3 GAMMA/KG

KETOROLAC + MORPHINE

Group Type ACTIVE_COMPARATOR

Ketorolac Tromethamine AND morphine

Intervention Type 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:

Interventions

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FENTANYL

FENTANYL CITRATE, NASAL, 3 GAMMA/KG

Intervention Type DRUG

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:

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No