Nasal Fentanyl And Renal Colic | NCT01339624

Studies
Nasal Fentanyl And Renal Colic

NCT01339624

Sponsor

Valduce Hospital

Status

Completed

Last Update Posted

Apr 20, 2011Estimated

Enrollment

65Actual

Phase

Not Applicable

Conditions

Acute Renal Colic

Interventions

FENTANYL
Ketorolac Tromethamine AND morphine

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Apr 15, 2011

First Submission Date that Met QC Criteria

Apr 19, 2011

First Posted Date

Apr 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2011

Last Update Posted Date

Apr 20, 2011Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NASAL FENTANYL,	Active Comparator		Drug: FENTANYL
KETOROLAC + MORPHINE	Active Comparator		Drug: Ketorolac Tromethamine AND morphine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FENTANYL	Drug	FENTANYL CITRATE, NASAL, 3 GAMMA/KG	NASAL FENTANYL,

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Use of rescue therapy at 30 minutes		30 MINUTES
The occurrence of adverse events		60 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Valduce Hospital		Como		22100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D056844	Renal Colic
D000377	Agnosia

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005283	Fentanyl
D020911	Ketorolac Tromethamine
D009020	Morphine

Ancestor Terms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D007213	Indomethacin

Browse Leaves

Not provided

Browse Branches

Not provided