PainPhase 4NCT01708122
Intranasal Fentanyl as an Analgesic for Cystoscopic Procedures
A Phase 4 study testing Fentanyl and saline in people with Pain, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Fentanyl and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Feb 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Urological indications for cystoscopic procedure.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harbor UCLA Medical Center Urology Clinic
Torrance, California, 90502
About this study
Official title: 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
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called fentanyl citrate
100 mcg in 1 mL intranasal spray
salineDrug
Also called normal saline
Sodium Chloride 0.9% intranasal spray
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl | Experimental | Subjects will receive either 0.5mL or 1 mL of intranasal fentanyl (50mcg or 100mcg) Receives: Drug: Fentanyl |
| Placebo | Placebo comparator | Subjects will receive either 0.5mL or 1 mL of intranasal saline as placebo. Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
Measured: Pre procedure, During procedure, Post procedure
Secondary outcomes (1)
O2 Saturation 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.
Measured: Baseline, 5 minutes 10 minutes and 30 minutes post drug-administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startMay 2009
- Primary completionMar 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard C Reznichek, MD, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Investigators
- Richard Reznichek, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708122
- Sponsor's protocol ID
- 13623-01
- Other IDs
- UL1TR000124
- Status last verified
- Jul 2015
- First submitted
- 30 Mar 2012
- Last updated
- 20 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01708122
- Acronym / sponsor ID
- 13623-01
- Conditions
- Pain
- Keywords
- Intranasal fentanyl, Cystoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Posted 20 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl | Experimental | Drug: FentanylSubjects will receive either 0.5mL or 1 mL of intranasal fentanyl (50mcg or 100mcg) |
| Placebo | Placebo comparator | Drug: salineSubjects will receive either 0.5mL or 1 mL of intranasal saline as placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Urological indications for cystoscopic procedure.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FentanylAlso: fentanyl citrate100 mcg in 1 mL intranasal spray | Drug | Fentanyl |
| salineAlso: normal salineSodium Chloride 0.9% intranasal spray | Drug | Placebo |
Primary outcome
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.
1 secondary outcome
O2 Saturation Post Drug Administration
Time frame: Baseline, 5 minutes 10 minutes and 30 minutes post drug-administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Reznichek, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl and saline in people with Pain, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre Procedure 0 - 10 Pain Numerical Rating Scale (time frame: Pre procedure, During procedure, Post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2015; AzTrials last refreshed its copy on 7 Nov 2026.