Trial Outcomes & Findings for Safety Study of Analgesia After Craniotomy Surgery With End Tidal (ET) Carbon Dioxide (CO2) Monitoring (NCT NCT01327677)
NCT ID: NCT01327677
Last Updated: 2017-05-31
Results Overview
Defined by minimum respiratory rate (breaths/minute).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
137 participants
Primary outcome timeframe
up to 24 hours postoperatively
Results posted on
2017-05-31
Participant Flow
Participant milestones
| Measure |
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
|
PCA Fentanyl
A patient can self-administer fentanyl intravenously using a Patient Controlled Analgesia (PCA) pump.
Fentanyl: 20mcg/demand dose with an 8 minute lock out
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
69
|
|
Overall Study
COMPLETED
|
48
|
56
|
|
Overall Study
NOT COMPLETED
|
20
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
As the result of patients either not completing the assigned intervention due to premature withdrawal from the protocol, protocol violations, or incomplete data capture, the number of analyzed patients was reduced compared to the originally allocated number.
Baseline characteristics by cohort
| Measure |
PRN Fentanyl
n=48 Participants
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
|
IVPCA Fentanyl
n=56 Participants
A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.
Fentanyl: 20mcg/demand dose with an 8 minute lock out
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.1 years
STANDARD_DEVIATION 14.0 • n=99 Participants • As the result of patients either not completing the assigned intervention due to premature withdrawal from the protocol, protocol violations, or incomplete data capture, the number of analyzed patients was reduced compared to the originally allocated number.
|
50.4 years
STANDARD_DEVIATION 13.7 • n=107 Participants • As the result of patients either not completing the assigned intervention due to premature withdrawal from the protocol, protocol violations, or incomplete data capture, the number of analyzed patients was reduced compared to the originally allocated number.
|
49.8 years
STANDARD_DEVIATION 13.8 • n=206 Participants • As the result of patients either not completing the assigned intervention due to premature withdrawal from the protocol, protocol violations, or incomplete data capture, the number of analyzed patients was reduced compared to the originally allocated number.
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants • As the result of patients either not completing the assigned intervention due to premature withdrawal from the protocol, protocol violations, or incomplete data capture, the number of analyzed patients was reduced compared to the originally allocated number.
|
25 Participants
n=107 Participants • As the result of patients either not completing the assigned intervention due to premature withdrawal from the protocol, protocol violations, or incomplete data capture, the number of analyzed patients was reduced compared to the originally allocated number.
|
51 Participants
n=206 Participants • As the result of patients either not completing the assigned intervention due to premature withdrawal from the protocol, protocol violations, or incomplete data capture, the number of analyzed patients was reduced compared to the originally allocated number.
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants • As the result of patients either not completing the assigned intervention due to premature withdrawal from the protocol, protocol violations, or incomplete data capture, the number of analyzed patients was reduced compared to the originally allocated number.
|
31 Participants
n=107 Participants • As the result of patients either not completing the assigned intervention due to premature withdrawal from the protocol, protocol violations, or incomplete data capture, the number of analyzed patients was reduced compared to the originally allocated number.
|
53 Participants
n=206 Participants • As the result of patients either not completing the assigned intervention due to premature withdrawal from the protocol, protocol violations, or incomplete data capture, the number of analyzed patients was reduced compared to the originally allocated number.
|
|
Race/Ethnicity, Customized
White
|
42 Participants
n=99 Participants • As the result of patients either not completing the assigned intervention due to premature withdrawal from the protocol, protocol violations, or incomplete data capture, the number of analyzed patients was reduced compared to the originally allocated number.
|
44 Participants
n=107 Participants • As the result of patients either not completing the assigned intervention due to premature withdrawal from the protocol, protocol violations, or incomplete data capture, the number of analyzed patients was reduced compared to the originally allocated number.
|
86 Participants
n=206 Participants • As the result of patients either not completing the assigned intervention due to premature withdrawal from the protocol, protocol violations, or incomplete data capture, the number of analyzed patients was reduced compared to the originally allocated number.
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=99 Participants • As the result of patients either not completing the assigned intervention due to premature withdrawal from the protocol, protocol violations, or incomplete data capture, the number of analyzed patients was reduced compared to the originally allocated number.
|
7 Participants
n=107 Participants • As the result of patients either not completing the assigned intervention due to premature withdrawal from the protocol, protocol violations, or incomplete data capture, the number of analyzed patients was reduced compared to the originally allocated number.
|
12 Participants
n=206 Participants • As the result of patients either not completing the assigned intervention due to premature withdrawal from the protocol, protocol violations, or incomplete data capture, the number of analyzed patients was reduced compared to the originally allocated number.
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants • As the result of patients either not completing the assigned intervention due to premature withdrawal from the protocol, protocol violations, or incomplete data capture, the number of analyzed patients was reduced compared to the originally allocated number.
|
5 Participants
n=107 Participants • As the result of patients either not completing the assigned intervention due to premature withdrawal from the protocol, protocol violations, or incomplete data capture, the number of analyzed patients was reduced compared to the originally allocated number.
|
6 Participants
n=206 Participants • As the result of patients either not completing the assigned intervention due to premature withdrawal from the protocol, protocol violations, or incomplete data capture, the number of analyzed patients was reduced compared to the originally allocated number.
|
PRIMARY outcome
Timeframe: up to 24 hours postoperativelyDefined by minimum respiratory rate (breaths/minute).
Outcome measures
| Measure |
PRN Fentanyl
n=48 Participants
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
|
PCA Fentanyl
n=56 Participants
A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.
Fentanyl: 20mcg/demand dose with an 8 minute lock out
|
|---|---|---|
|
Respiratory Depression
|
10.9 breaths/minute
Standard Error 0.4
|
10.5 breaths/minute
Standard Error 0.4
|
PRIMARY outcome
Timeframe: Up to 24 hours postoperatively.Defined by maximal End Tidal CO2 (mmHg)
Outcome measures
| Measure |
PRN Fentanyl
n=48 Participants
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
|
PCA Fentanyl
n=56 Participants
A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.
Fentanyl: 20mcg/demand dose with an 8 minute lock out
|
|---|---|---|
|
Respiratory Depression
|
41.4 mmHg
Standard Error 0.6
|
41.1 mmHg
Standard Error 0.7
|
SECONDARY outcome
Timeframe: up to 24 hours postoperativelyDefined by minimum oxygen saturation (SaO2)
Outcome measures
| Measure |
PRN Fentanyl
n=48 Participants
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
|
PCA Fentanyl
n=56 Participants
A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.
Fentanyl: 20mcg/demand dose with an 8 minute lock out
|
|---|---|---|
|
Hypoxia
|
95.8 Percent Oxygen Saturation
Standard Error 0.2
|
96.3 Percent Oxygen Saturation
Standard Error 0.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 24 hours postoperativelyAmount of cumulative fentanyl consumed in mcg
Outcome measures
| Measure |
PRN Fentanyl
n=48 Participants
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
|
PCA Fentanyl
n=56 Participants
A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.
Fentanyl: 20mcg/demand dose with an 8 minute lock out
|
|---|---|---|
|
Mean Fentanyl Consumption
|
16.5 micrograms/ hour
Standard Error 2.65
|
26.4 micrograms/ hour
Standard Error 2.5
|
Adverse Events
PRN Fentanyl
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PCA Fentanyl
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Athir Morad, M.D.
Johns Hopkins University School of Medicine
Phone: 4109552611
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place