Intranasal Fentanyl as an Analgesic for Cystoscopic Procedures
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2009 |
| End Date: | February 2014 |
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.
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.
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.
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.
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.
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