Phase 4 N=53 Randomized Quadruple-blind Supportive Care

Intranasal Fentanyl as an Analgesic for Cystoscopic Procedures

Pain

Bottom Line

View on ClinicalTrials.gov: NCT01708122 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2015

Primary outcome: Primary: Pre Procedure 0 - 10 Pain Numerical Rating Scale — 0; 0; 7; 5 0 - 10 Pain Numerical Rating Scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Fentanyl (Drug); saline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Primary completion: Mar 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Pre Procedure 0 - 10 Pain Numerical Rating Scale	0; 0; 7; 5; 0; 0	—
SECONDARY O2 Saturation Post Drug Administration	99.4; 99.3; 99.3; 99.3; 99.5; 99.4	—

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.

Eligibility Criteria

Inclusion Criteria

Urological indications for cystoscopic procedure.

Exclusion Criteria

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)
0-10 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.

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Data sourced from ClinicalTrials.gov (NCT01708122). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.