Pain
Conditions
Keywords
pain management, opioid analgesic therapy, safety, craniotomy
Brief summary
This research is being done to compare two methods of giving fentanyl, a narcotic often given to patients following brain surgery and determine if one method has more side effects than the other. Both of these methods are available in the postoperative treatment of pain. This research also is being done to determine if patients receiving narcotic pain medicine will benefit from additional monitoring of carbon dioxide levels. Since narcotic pain medicines can slow down breathing, The investigators want to see if measuring exhaled carbon dioxide levels will help identify a slower breathing rate and improve safety.
Detailed description
See brief summary
Interventions
DRUGFentanyl
25-50 mcg every 20 minutes
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult male and female, English speaking patients undergoing supratentorial craniotomy for tumor under general anesthesia at the Johns Hopkins Hospital will be eligible for this study.
Exclusion criteria
* pregnant women * patients with post operative neurological changes * patients who remain intubated post-operatively * patients who require the use of concomitant administration of sedatives * patients who are unable to initiate a PCA bolus * patients who are unable to communicate verbally * patients who are allergic to fentanyl * patients who have a history of narcotic abuse * patients who have a history of chronic pain requiring opioids * patients who have been in any investigational drug trial within 1 month of the treatment day * patients who have chronic respiratory insufficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Depression | up to 24 hours postoperatively | Defined by minimum respiratory rate (breaths/minute). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoxia | up to 24 hours postoperatively | Defined by minimum oxygen saturation (SaO2) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Fentanyl Consumption | up to 24 hours postoperatively | Amount of cumulative fentanyl consumed in mcg |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PRN Fentanyl A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.
Fentanyl: 25-50 mcg every 20 minutes | 48 |
| IVPCA Fentanyl A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.
Fentanyl: 20mcg/demand dose with an 8 minute lock out | 56 |
| Total | 104 |
Baseline characteristics
| Characteristic | IVPCA Fentanyl | Total | PRN Fentanyl |
|---|---|---|---|
| Age, Continuous | 50.4 years STANDARD_DEVIATION 13.7 | 49.8 years STANDARD_DEVIATION 13.8 | 49.1 years STANDARD_DEVIATION 14 |
| Race/Ethnicity, Customized Black | 7 Participants | 12 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 6 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 44 Participants | 86 Participants | 42 Participants |
| Sex: Female, Male Female | 25 Participants | 51 Participants | 26 Participants |
| Sex: Female, Male Male | 31 Participants | 53 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 56 |
| other Total, other adverse events | 0 / 48 | 0 / 56 |
| serious Total, serious adverse events | 0 / 48 | 0 / 56 |
Outcome results
Primary
Respiratory Depression
Defined by minimum respiratory rate (breaths/minute).
Time frame: up to 24 hours postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRN Fentanyl | Respiratory Depression | 10.9 breaths/minute | Standard Error 0.4 |
| PCA Fentanyl | Respiratory Depression | 10.5 breaths/minute | Standard Error 0.4 |
Primary
Respiratory Depression
Defined by maximal End Tidal CO2 (mmHg)
Time frame: Up to 24 hours postoperatively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRN Fentanyl | Respiratory Depression | 41.4 mmHg | Standard Error 0.6 |
| PCA Fentanyl | Respiratory Depression | 41.1 mmHg | Standard Error 0.7 |
Secondary
Hypoxia
Defined by minimum oxygen saturation (SaO2)
Time frame: up to 24 hours postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRN Fentanyl | Hypoxia | 95.8 Percent Oxygen Saturation | Standard Error 0.2 |
| PCA Fentanyl | Hypoxia | 96.3 Percent Oxygen Saturation | Standard Error 0.2 |
Other Pre-specified
Mean Fentanyl Consumption
Amount of cumulative fentanyl consumed in mcg
Time frame: up to 24 hours postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRN Fentanyl | Mean Fentanyl Consumption | 16.5 micrograms/ hour | Standard Error 2.65 |
| PCA Fentanyl | Mean Fentanyl Consumption | 26.4 micrograms/ hour | Standard Error 2.5 |