Trial Outcomes & Findings for IVPCA in the Management of Pain Following Major Intracranial Surgery (NCT NCT00286221)

NCT ID: NCT00286221

Last Updated: 2017-09-26

Results Overview

Patients' Numerical Rating Scale scores (0-10: 0 = no pain, 10 = worst imaginable pain)

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 159 participants
• Primary outcome timeframe: Up to 16 hours
• Results posted on: 2017-09-26

Participant Flow

Participant milestones

Measure	Supratentorial PCA Fentanyl PCA fentanyl: Patient controlled analgesia (PCA) fentanyl 0.5 ug/kg with a dosing interval ("lockout") of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted	Supratentorial PRN Fentanyl PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))	Infratentorial PCA Fentanyl PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval ("lockout") of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted	Infratentorial PRN Fentanyl PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
Overall Study STARTED	39	40	40	40
Overall Study COMPLETED	29	35	31	34
Overall Study NOT COMPLETED	10	5	9	6

Reasons for withdrawal

Measure	Supratentorial PCA Fentanyl PCA fentanyl: Patient controlled analgesia (PCA) fentanyl 0.5 ug/kg with a dosing interval ("lockout") of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted	Supratentorial PRN Fentanyl PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))	Infratentorial PCA Fentanyl PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval ("lockout") of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted	Infratentorial PRN Fentanyl PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
Overall Study Protocol Violation	2	1	6	4
Overall Study Unanticipated Neurosurgical Complication	6	3	3	2
Overall Study Inability to trigger PCA	2	0	0	0
Overall Study Unrecognized exclusion criteria met	0	1	0	0

Baseline Characteristics

IVPCA in the Management of Pain Following Major Intracranial Surgery

Baseline characteristics by cohort

Measure	Supratentorial PCA Fentanyl n=29 Participants PCA fentanyl: Patient controlled analgesia (PC fentanyl 0.5 ug/kg with a dosing interval ("lockout") of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted	Supratentorial PRN Fentanyl n=35 Participants PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes pro re nata (PRN) (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))	Infratentorial PCA Fentanyl n=31 Participants PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval ("lockout") of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted	Infratentorial PRN Fentanyl n=34 Participants PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))	Total n=129 Participants Total of all reporting groups
Age, Continuous	48.2 years STANDARD_DEVIATION 11.9 • n=5 Participants	47.8 years STANDARD_DEVIATION 15.0 • n=7 Participants	45.4 years STANDARD_DEVIATION 14.6 • n=5 Participants	41.4 years STANDARD_DEVIATION 11.1 • n=4 Participants	45.6 years STANDARD_DEVIATION 13.2 • n=21 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	17 Participants n=7 Participants	20 Participants n=5 Participants	21 Participants n=4 Participants	76 Participants n=21 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	18 Participants n=7 Participants	11 Participants n=5 Participants	13 Participants n=4 Participants	53 Participants n=21 Participants
Region of Enrollment United States	29 Participants n=5 Participants	35 Participants n=7 Participants	31 Participants n=5 Participants	34 Participants n=4 Participants	129 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to 16 hours

Patients' Numerical Rating Scale scores (0-10: 0 = no pain, 10 = worst imaginable pain)

Outcome measures

Measure	Supratentorial PCA Fentanyl n=29 Participants PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval ("lockout") of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted	Supratentorial PRN Fentanyl n=35 Participants PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))	Infratentorial PCA Fentanyl n=31 Participants PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval ("lockout") of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted	Infratentorial PRN Fentanyl n=34 Participants PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
Hourly Pain Scores	2.5 units on a scale Standard Deviation 2.0	3.6 units on a scale Standard Deviation 2.1	3.7 units on a scale Standard Deviation 1.9	5.2 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: Up to 16 hours

the amount of fentanyl is that administered in response to corresponding rest pain levels. Thus, the 0 hour indicates the amount of fentanyl administered from the time of admission until the end of the first hour. Also note that once pain assessments are made every other hour (e.g., 10, 12, 14, and 16), the analgesic totals indicated are for the corresponding 2-hour period after the pain assessment, and were halved to estimate the hourly rate of analgesic consumption.

Outcome measures

Measure	Supratentorial PCA Fentanyl n=29 Participants PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval ("lockout") of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted	Supratentorial PRN Fentanyl n=35 Participants PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))	Infratentorial PCA Fentanyl n=31 Participants PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval ("lockout") of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted	Infratentorial PRN Fentanyl n=34 Participants PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
Fentanyl Consumption	44.1 mcg/hour Standard Deviation 34.5	23.6 mcg/hour Standard Deviation 23.7	54.8 mcg/hour Standard Deviation 34.8	29.9 mcg/hour Standard Deviation 16.4

Adverse Events

Supratentorial PCA Fentanyl

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Supratentorial PRN Fentanyl

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Infratentorial PCA Fentanyl

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Infratentorial PRN 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

Dr. Bradford Winters

Johns Hopkins School of Medicine

Phone: 4109559080

Email: bwinter1@jh.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place