- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01708122
Intranasal Fentanyl as an Analgesic for Cystoscopic Procedures
A Prospective, Randomized, Double Blind Study Comparing the Efficacy and Safety of Fentanyl Nasal Spray to Placebo as an Analgesic, in Patients Undergoing Outpatient Cystoscopic Procedures
Study Overview
Detailed Description
In this double-blind study, a nasal spray of either the drug (fentanyl -- an opioid analgesic) or placebo (normal saline) is administered before the procedure. There is a 50% chance that patients receive the drug or the placebo. In either case, local Lidocaine jelly is used as an anesthetic in the urethra. Each patient is compensated for time and traveling after the completion of his/her participation.
Patients are asked to arrive between 7 and 11 PM on the evening prior to their procedure for an overnight admission to 5 East ward, on the 5th floor of the Harbor UCLA Medical Center in Torrance, California, United States. Once there, vital signs (blood pressure, pulse, oxygen saturation -- amount of oxygen in the blood, and breathing rate) is checked and an intravenous line is placed. Before, during and after the procedure, patients are asked to rate their pain on a scale of 0 to 10 with 0 being "no pain" and 10 being "the worst pain possible."
Regardless of whether patients are assigned to receive fentanyl or placebo, they receive the standard of care for this cystoscopic procedure.
Once in the cystoscopy room, patients receive the study drug by nasal (into the nose) spray. The study drug is supplied in a pre-filled syringe that contains either 100 mcg of fentanyl or placebo (normal saline with no active medicine in it). Once the study drug is given, the vital signs are closely monitored(checked) until the effect of drug wears off, usually between 2 and 4 hours.
Blood samples are drawn on several occasions. This blood is used to see how much of the study drug (fentanyl or placebo) appears in the blood.
Adverse effects: The well-known adverse effects of opioids may occur after nasal as well as conventional routes of administration; however, severe adverse effects such as respiratory depression or hypotension do not seem to occur in any appreciable frequency.
Intranasal fentanyl has been used safely and effectively in many studies. There are no reports of any serious side effects with the small dose (100 mcg) that is being used in this study. Intranasal fentanyl is generally well tolerated with no serious adverse events. In cancer patients treated for breakthrough pain, the main treatment related side effects were nausea, vertigo, dizziness, constipation, and somnolence. For local side effects, fentanyl displays little local irritation, nasal discomfort or taste experiences. Nasal irritation, skin pain, nasal mucosa ulcers and dysgeusia have been occasionally reported as minor side effects.
The following minor side effects have been reported with other forms of fentanyl (oral, patch or intravenous): anxiety; confusion; difficulty walking; dizziness; drowsiness; dry mouth; headache; itching; nausea and vomiting.
The following severe side effects have not been reported with intranasal fentanyl but have been reported with other forms of fentanyl (oral, patch or intravenous): allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); excessive dizziness; excessive drowsiness; fainting; fatigue; hallucinations; muscle rigidity; seizures; shock (changes in skin color); slow heartbeat; respiratory depression or slowed breathing; trouble breathing and feeling of weakness.
Advantages to patients: If effective, less pain during and after the cystoscopic procedure and better tolerance of the procedure.
Advantages to humanity: If effective, nasal fentanyl could be used as a means to reduce pain before and during cystoscopic procedures.
These benefits may not happen and unexpected side effects may develop.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
California
-
Torrance, California, United States, 90502
- Harbor UCLA Medical Center Urology Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fentanyl
Subjects will receive either 0.5mL or 1 mL of intranasal fentanyl (50mcg or 100mcg)
|
100 mcg in 1 mL intranasal spray
Other Names:
|
Placebo Comparator: Placebo
Subjects will receive either 0.5mL or 1 mL of intranasal saline as placebo.
|
Sodium Chloride 0.9% intranasal spray
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pre Procedure 0 - 10 Pain Numerical Rating Scale
Time Frame: Pre procedure, During procedure, Post procedure
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
O2 Saturation Post Drug Administration
Time Frame: Baseline, 5 minutes 10 minutes and 30 minutes post drug-administration.
|
After administration of the study drug, the subject is monitored (oxygen saturation), for any signs of respiratory depression or the presence of complications or side-effects including apnea or oxygen desaturation.
|
Baseline, 5 minutes 10 minutes and 30 minutes post drug-administration.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13623-01
- UL1TR000124 (U.S. NIH Grant/Contract)
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.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on Fentanyl
-
University of Maryland, BaltimoreFood and Drug Administration (FDA)CompletedPeer Review, ResearchUnited States
-
Alexza Pharmaceuticals, Inc.Completed
-
University of Maryland, BaltimoreFood and Drug Administration (FDA)Completed
-
University of Texas Southwestern Medical CenterCompletedPregnancyUnited States
-
Samuel Lunenfeld Research Institute, Mount Sinai...Terminated
-
University of PatrasUnknownStillborn Caesarean SectionGreece
-
Janssen Research & Development, LLCCompleted
-
Johns Hopkins UniversityCompletedIntracranial SurgeryUnited States
-
Ente Ospedaliero Cantonale, BellinzonaNot yet recruiting