NCT01708122

Brief Summary

The purpose of this study is to assess the efficacy of intranasally-administrated fentanyl spray 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 pain. In this study, an additional medicine (fentanyl) is used to reduce pain that occurs during and after the above procedure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started May 2009

Longer than P75 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2012

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

August 20, 2015

Completed
Last Updated

August 20, 2015

Status Verified

July 1, 2015

Enrollment Period

3.8 years

First QC Date

March 30, 2012

Results QC Date

July 25, 2015

Last Update Submit

July 25, 2015

Conditions

Pain

Keywords

Intranasal fentanylCystoscopy

Outcome Measures

Primary Outcomes (1)

  • Pre Procedure 0 - 10 Pain Numerical Rating Scale

    The NRS pain assessment (0 = no pain to 10 = worst possible pain) is recorded as outlined below: 1\. baseline pain score at admission, when the subject checks in, 2 Upon entry of the cystoscope into the urethral meatus, 3. and thirty minutes after the cystoscopic procedure has been completed.

    Pre procedure, During procedure, Post procedure

Secondary Outcomes (1)

  • O2 Saturation Post Drug Administration

    Baseline, 5 minutes 10 minutes and 30 minutes post drug-administration.

Study Arms (2)

Fentanyl

EXPERIMENTAL

Subjects will receive either 0.5mL or 1 mL of intranasal fentanyl (50mcg or 100mcg)

Drug: Fentanyl

Placebo

PLACEBO COMPARATOR

Subjects will receive either 0.5mL or 1 mL of intranasal saline as placebo.

Drug: saline

Interventions

FentanylDRUG

100 mcg in 1 mL intranasal spray

Also known as: fentanyl citrate
Fentanyl
salineDRUG

Sodium Chloride 0.9% intranasal spray

Also known as: normal saline
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Urological indications for cystoscopic procedure.

You may not qualify if:

  • History of analgesia abuse or former opioid addiction.
  • Allergy to fentanyl.
  • Acute/chronic nasal problems such as rhinitis or sinusitis.
  • Positive urine pregnancy test / lactation.
  • Acute bronchial asthma / upper airway obstruction.
  • Presence of bradycardia or a history of seizures.
  • Concomitant use of drugs that inhibit CYP3A4 (e.g., ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, MAO inhibitors and verapamil)
  • NRS pain score more than 3 on baseline.
  • Any situation or condition which, in the investigator's opinion, puts the subject at significant risk, or could confound the study results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harbor UCLA Medical Center Urology Clinic

Torrance, California, 90502, United States

Location

MeSH Terms

Conditions

Pain

Interventions

FentanylSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Richard Reznichek
Organization
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center - Urology
RReznichek@dhs.lacounty.gov
3102222724

Study Officials

  • Richard Reznichek, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

March 30, 2012

First Posted

October 16, 2012

Study Start

May 1, 2009

Primary Completion

March 1, 2013

Study Completion

February 1, 2014

Last Updated

August 20, 2015

Results First Posted

August 20, 2015

Record last verified: 2015-07

Locations

US(1)