Intranasal Fentanyl as an Analgesic for Cystoscopic Procedures

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Los Angeles Biomedical Research Institute; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Treatments: Analgesics; Fentanyl

Criteria

Inclusion Criteria:

1. Urological indications for cystoscopic procedure.

Exclusion Criteria:

1. History of analgesia abuse or former opioid addiction.

2. Allergy to fentanyl.

3. Acute/chronic nasal problems such as rhinitis or sinusitis.

4. Positive urine pregnancy test / lactation.

5. Acute bronchial asthma / upper airway obstruction.

6. Presence of bradycardia or a history of seizures.

7. 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)

8. 0-10 NRS pain score more than 3 on baseline.

9. Any situation or condition which, in the investigator's opinion, puts the subject at significant risk, or could confound the study results.