Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures

May 10, 2017 updated by: Richard C Reznichek, MD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Torrance, California, United States, 90502
        • Urology Clinic, Harbor-UCLA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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:

  1. History of analgesic abuse or opioid tolerance
  2. Allergy to fentanyl or to any of the components of Lazanda®
  3. Acute/chronic nasal problems such as rhinitis or sinusitis
  4. Acute bronchial asthma / upper airway obstruction
  5. Presence of bradycardia or history of seizures
  6. 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.
  7. Concomitant use of vasoconstrictive nasal decongestants (e.g., oxymetazoline, phenylephrine, xylometazoline)
  8. Numeric Rating Scale (NRS) pain score more than 0 at baseline
  9. Any situation or condition which, in the investigator's opinion, puts the subject at significant risk, or could confound the study results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intranasal Fentanyl 100mcg
fentanyl pectin nasal spray 100mcg
Drug: Fentanyl pectin
comparison of Intranasal fentanyl 100mcg vs 200 mcg.
Other Names:
  • Fentanyl
  • Lazanda
EXPERIMENTAL: Intranasal Fentanyl 200mcg
fentanyl pectin nasal spray 200mcg
Drug: Fentanyl pectin
comparison of Intranasal fentanyl 100mcg vs 200 mcg.
Other Names:
  • Fentanyl
  • Lazanda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in pain numeric rating scale
Time Frame: within 3 hours post administration of the drug

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).
within 3 hours post administration of the drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxyhemoglobin saturation
Time Frame: Every 5 minutes post administration of the drug until 3 hours
Pulse oximetry will be recorded at baseline and every 5 minutes for 3 hours post drug-administration.
Every 5 minutes post administration of the drug until 3 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean arterial blood pressure
Time Frame: every 15 minutes until 3 hours post drug-administration
Will be recorded at baseline and every 15 minutes for 3 hours post drug-administration.
every 15 minutes until 3 hours post drug-administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Richard C Reznichek, MD

Collaborators

Depomed

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2013

Primary Completion (ACTUAL)

May 10, 2016

Study Completion (ACTUAL)

May 10, 2016

Study Registration Dates

First Submitted

December 20, 2012

First Submitted That Met QC Criteria

December 20, 2012

First Posted (ESTIMATE)

December 27, 2012

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20812-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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