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Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures

Primary Purpose

Other Acute Pain, Pain Experienced During Cystoscopy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Fentanyl pectin

About this trial

This is an interventional supportive care trial for Other Acute Pain focused on measuring Intranasal fentanyl, Cystoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

1. Male adult patients scheduled for cystoscopy; additional procedures (e.g. ureteral stent placement, stent exchange, bladder biopsy, retrograde pyelogram) may be included.

Exclusion Criteria:

History of analgesic abuse or opioid tolerance
Allergy to fentanyl or to any of the components of Lazanda®
Acute/chronic nasal problems such as rhinitis or sinusitis
Acute bronchial asthma / upper airway obstruction
Presence of bradycardia or history of seizures
Concomitant use of drugs that inhibit cytochrome P450 isoenzyme 3A4 (e.g., ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, monoamine oxidase inhibitors and verapamil) or exposure to these drugs 30 days prior to placement on the study.
Concomitant use of vasoconstrictive nasal decongestants (e.g., oxymetazoline, phenylephrine, xylometazoline)
Numeric Rating Scale (NRS) pain score more than 0 at baseline
Any situation or condition which, in the investigator's opinion, puts the subject at significant risk, or could confound the study results.

Sites / Locations

Urology Clinic, Harbor-UCLA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Intranasal Fentanyl 100mcg

Intranasal Fentanyl 200mcg

Arm Description

fentanyl pectin nasal spray 100mcg

fentanyl pectin nasal spray 200mcg

Outcomes

Primary Outcome Measures

Change from baseline in pain numeric rating scale

The primary endpoint is the worst pain experienced at any time during the procedure. Pain will be assessed using the Numeric Rating Scale (NRS score 0 = no pain to 10 = worst possible pain).

Secondary Outcome Measures

Oxyhemoglobin saturation

Pulse oximetry will be recorded at baseline and every 5 minutes for 3 hours post drug-administration.

Full Information

NCT ID

NCT01756651

First Posted

December 20, 2012

Last Updated

May 10, 2017

Sponsor

Richard C Reznichek, MD

Collaborators

Depomed

1. Study Identification

Unique Protocol Identification Number

NCT01756651

Brief Title

Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures

Official Title

A Prospective Study Comparing the Efficacy and Safety of 100 mcg and 200 mcg of Intranasal Fentanyl Pectin Spray as an Analgesic in Adult Males Undergoing Outpatient Cystoscopic Procedures

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

February 2013 (Actual)

Primary Completion Date

May 10, 2016 (Actual)

Study Completion Date

May 10, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Richard C Reznichek, MD

Collaborators

Depomed

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to assess the safety and efficacy of intranasally-administrated fentanyl pectin spray (Lazanda®)given to decrease the pain during cystoscopy (the passage of a telescopic instrument into the bladder for purpose of diagnosing the cause of blood in the urine, urinary complaints or any other problems with the urinary bladder). The current standard practice is to use Lidocaine jelly (a local anesthetic) given through the urethra to lubricate and decrease local pain. In this study, an additional medicine (Lazanda®) is used to reduce pain that occurs during and after the above procedure.

Detailed Description

In this prospective study, twenty subjects will be enrolled. The first ten will receive a dose of 100mcg pectin fentanyl nasal spray (Lazanda®). The second ten will receive a dose of 200mcg pectin fentanyl nasal spray (Lazanda®) if the 100mcg was well tolerated in the first ten. In all cases, Lidocaine jelly is used as an local anesthetic in the urethra.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Other Acute Pain, Pain Experienced During Cystoscopy

Keywords

Intranasal fentanyl, Cystoscopy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intranasal Fentanyl 100mcg

Arm Type

Experimental

Arm Description

fentanyl pectin nasal spray 100mcg

Arm Title

Intranasal Fentanyl 200mcg

Arm Type

Experimental

Arm Description

fentanyl pectin nasal spray 200mcg

Intervention Type

Drug

Intervention Name(s)

Fentanyl pectin

Other Intervention Name(s)

Lazanda, Fentanyl

Intervention Description

comparison of Intranasal fentanyl 100mcg vs 200 mcg.

Primary Outcome Measure Information:

Title

Change from baseline in pain numeric rating scale

Description

The primary endpoint is the worst pain experienced at any time during the procedure. Pain will be assessed using the Numeric Rating Scale (NRS score 0 = no pain to 10 = worst possible pain).

Time Frame

within 3 hours post administration of the drug

Secondary Outcome Measure Information:

Title

Oxyhemoglobin saturation

Description

Pulse oximetry will be recorded at baseline and every 5 minutes for 3 hours post drug-administration.

Time Frame

Every 5 minutes post administration of the drug until 3 hours

Other Pre-specified Outcome Measures:

Title

Mean arterial blood pressure

Description

Will be recorded at baseline and every 15 minutes for 3 hours post drug-administration.

Time Frame

every 15 minutes until 3 hours post drug-administration

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1. Male adult patients scheduled for cystoscopy; additional procedures (e.g. ureteral stent placement, stent exchange, bladder biopsy, retrograde pyelogram) may be included. Exclusion Criteria: History of analgesic abuse or opioid tolerance Allergy to fentanyl or to any of the components of Lazanda® Acute/chronic nasal problems such as rhinitis or sinusitis Acute bronchial asthma / upper airway obstruction Presence of bradycardia or history of seizures Concomitant use of drugs that inhibit cytochrome P450 isoenzyme 3A4 (e.g., ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, monoamine oxidase inhibitors and verapamil) or exposure to these drugs 30 days prior to placement on the study. Concomitant use of vasoconstrictive nasal decongestants (e.g., oxymetazoline, phenylephrine, xylometazoline) Numeric Rating Scale (NRS) pain score more than 0 at baseline Any situation or condition which, in the investigator's opinion, puts the subject at significant risk, or could confound the study results.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Reznichek, MD

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

Urology Clinic, Harbor-UCLA Medical Center

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

12. IPD Sharing Statement

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Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures

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