Trial Outcomes & Findings for Intranasal Fentanyl as an Analgesic for Cystoscopic Procedures (NCT NCT01708122)
NCT ID: NCT01708122
Last Updated: 2015-08-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
71 participants
Primary outcome timeframe
Pre procedure, During procedure, Post procedure
Results posted on
2015-08-20
Participant Flow
Seventy-one patients agreed to participate in the study and signed informed consent. Nine patients declined to proceed. Seven did not pass pre-anesthesia screening due to pre-existing medical conditions. Cystoscopic procedures were deemed no longer indicated for two patients. Ultimately, 53 patients were randomized and completed the study.
Participant milestones
| Measure |
Placebo
Subjects will receive 0.1 mL of intranasal saline as placebo.
saline: Sodium Chloride 0.9% intranasal spray
|
Fentanyl
Subjects receiving either 50mcg or 100mcg
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
|
Overall Study
COMPLETED
|
27
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intranasal Fentanyl as an Analgesic for Cystoscopic Procedures
Baseline characteristics by cohort
| Measure |
Fentanyl
n=26 Participants
Subjects will receive 50 to 100 mcg intranasal fentanyl
Fentanyl: 100 mcg in 1 mL intranasal spray
|
Placebo
n=27 Participants
Subjects will receive intranasal saline as placebo.
Saline: Sodium Chloride 0.9% intranasal spray
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.2 years
n=93 Participants
|
47.1 years
n=4 Participants
|
46.2 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=93 Participants
|
27 participants
n=4 Participants
|
53 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Pre procedure, During procedure, Post procedureThe 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.
Outcome measures
| Measure |
Fentanyl
n=26 Participants
Subjects will receive 50 to 100 mcg intranasal fentanyl
Fentanyl: 100 mcg in 1 mL intranasal spray
|
Placebo
n=27 Participants
Subjects will receive intranasal saline as placebo.
Saline: Sodium Chloride 0.9% intranasal spray
|
|---|---|---|
|
Pre Procedure 0 - 10 Pain Numerical Rating Scale
Pre-procedure
|
0 0 - 10 Pain Numerical Rating Scale
Interval 0.0 to 7.0
|
0 0 - 10 Pain Numerical Rating Scale
Interval 0.0 to 6.0
|
|
Pre Procedure 0 - 10 Pain Numerical Rating Scale
During procedure
|
7 0 - 10 Pain Numerical Rating Scale
Interval 0.0 to 10.0
|
5 0 - 10 Pain Numerical Rating Scale
Interval 0.0 to 10.0
|
|
Pre Procedure 0 - 10 Pain Numerical Rating Scale
Post Procedure
|
0 0 - 10 Pain Numerical Rating Scale
Interval 0.0 to 7.0
|
0 0 - 10 Pain Numerical Rating Scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Fentanyl
n=26 Participants
Subjects will receive 50 to 100 mcg intranasal fentanyl
Fentanyl: 100 mcg in 1 mL intranasal spray
|
Placebo
n=27 Participants
Subjects will receive intranasal saline as placebo.
Saline: Sodium Chloride 0.9% intranasal spray
|
|---|---|---|
|
O2 Saturation Post Drug Administration
Baseline
|
99.4 percentage of O2 Saturation
Interval 96.0 to 100.0
|
99.3 percentage of O2 Saturation
Interval 96.0 to 100.0
|
|
O2 Saturation Post Drug Administration
5 minutes
|
99.3 percentage of O2 Saturation
Interval 97.0 to 100.0
|
99.3 percentage of O2 Saturation
Interval 96.0 to 100.0
|
|
O2 Saturation Post Drug Administration
10 Minutes
|
99.5 percentage of O2 Saturation
Interval 97.0 to 100.0
|
99.4 percentage of O2 Saturation
Interval 96.0 to 100.0
|
|
O2 Saturation Post Drug Administration
30 Minutes
|
99.3 percentage of O2 Saturation
Interval 96.0 to 100.0
|
99.4 percentage of O2 Saturation
Interval 96.0 to 100.0
|
Adverse Events
Fentanyl
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fentanyl
n=26 participants at risk
Subjects receiving either 0.5mL or 1 mL of intranasal fentanyl (50mcg or 100mcg)
Fentanyl: 100 mcg in 1 mL intranasal spray
|
Placebo
n=27 participants at risk
Subjects receiving either 0.5mL or 1 mL intranasal saline as placebo.
Saline: Sodium Chloride 0.9% intranasal spray
|
|---|---|---|
|
General disorders
Nausea
|
7.7%
2/26 • Number of events 2 • From administration of study drug until 3 hours post administration
By direct questioning regarding the presence of the following: Nasal Irritation, nausea, vomiting, dizziness, respiratory distress, confusion, headache, dry mouth and any other discomfort no related to the surgical procedure with the possible answers yes or no. Subject can also report spontaneously during their stay in the department.
|
3.7%
1/27 • Number of events 1 • From administration of study drug until 3 hours post administration
By direct questioning regarding the presence of the following: Nasal Irritation, nausea, vomiting, dizziness, respiratory distress, confusion, headache, dry mouth and any other discomfort no related to the surgical procedure with the possible answers yes or no. Subject can also report spontaneously during their stay in the department.
|
|
General disorders
Dizziness
|
7.7%
2/26 • Number of events 2 • From administration of study drug until 3 hours post administration
By direct questioning regarding the presence of the following: Nasal Irritation, nausea, vomiting, dizziness, respiratory distress, confusion, headache, dry mouth and any other discomfort no related to the surgical procedure with the possible answers yes or no. Subject can also report spontaneously during their stay in the department.
|
0.00%
0/27 • From administration of study drug until 3 hours post administration
By direct questioning regarding the presence of the following: Nasal Irritation, nausea, vomiting, dizziness, respiratory distress, confusion, headache, dry mouth and any other discomfort no related to the surgical procedure with the possible answers yes or no. Subject can also report spontaneously during their stay in the department.
|
|
General disorders
headache
|
3.8%
1/26 • Number of events 1 • From administration of study drug until 3 hours post administration
By direct questioning regarding the presence of the following: Nasal Irritation, nausea, vomiting, dizziness, respiratory distress, confusion, headache, dry mouth and any other discomfort no related to the surgical procedure with the possible answers yes or no. Subject can also report spontaneously during their stay in the department.
|
7.4%
2/27 • Number of events 2 • From administration of study drug until 3 hours post administration
By direct questioning regarding the presence of the following: Nasal Irritation, nausea, vomiting, dizziness, respiratory distress, confusion, headache, dry mouth and any other discomfort no related to the surgical procedure with the possible answers yes or no. Subject can also report spontaneously during their stay in the department.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Irritation
|
23.1%
6/26 • Number of events 6 • From administration of study drug until 3 hours post administration
By direct questioning regarding the presence of the following: Nasal Irritation, nausea, vomiting, dizziness, respiratory distress, confusion, headache, dry mouth and any other discomfort no related to the surgical procedure with the possible answers yes or no. Subject can also report spontaneously during their stay in the department.
|
3.7%
1/27 • Number of events 1 • From administration of study drug until 3 hours post administration
By direct questioning regarding the presence of the following: Nasal Irritation, nausea, vomiting, dizziness, respiratory distress, confusion, headache, dry mouth and any other discomfort no related to the surgical procedure with the possible answers yes or no. Subject can also report spontaneously during their stay in the department.
|
Additional Information
Richard Reznichek
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center - Urology
Phone: 3102222724
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place