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This is a prospective, randomized controlled clinical trial to evaluate the efficacy and safety of intravenous patient controlled analgesia (IVPCA) in patients following major intracranial surgery (e.g. brain tumors, vascular surgery). We will compare pain, opioid consumption, costs, sedation level, length of hospital stay, patient satisfaction, and complications in patients randomized to receive either pro re nata (PRN) or IVPCA opioids. We hypothesize that IVPCA will be more efficacious than PRN opioids in the treatment of postoperative without an increased incidence of adverse effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supratentorial PCA fentanyl | Experimental |
| |
| Supratentorial PRN fentanyl | Active Comparator |
| |
| Infratentorial PCA fentanyl | Experimental |
| |
| Infratentorial PRN fentanyl | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCA fentanyl | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hourly Pain Scores | Patients' Numerical Rating Scale scores (0-10: 0 = no pain, 10 = worst imaginable pain) | Up to 16 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Fentanyl Consumption | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradford Winters, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19249923 | Result | Morad AH, Winters BD, Yaster M, Stevens RD, White ED, Thompson RE, Weingart JD, Gottschalk A. Efficacy of intravenous patient-controlled analgesia after supratentorial intracranial surgery: a prospective randomized controlled trial. Clinical article. J Neurosurg. 2009 Aug;111(2):343-50. doi: 10.3171/2008.11.JNS08797. | |
| 22156333 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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)) |
| FG002 | 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 |
| FG003 | 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)) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Supratentorial PCA Fentanyl | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hourly Pain Scores | Patients' Numerical Rating Scale scores (0-10: 0 = no pain, 10 = worst imaginable pain) | Posted | Mean | Standard Deviation | units on a scale | Up to 16 hours |
|
Adverse events data were collected only during the time of patient enrollment in the study, up to 16 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Supratentorial 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bradford Winters | Johns Hopkins School of Medicine | 4109559080 | bwinter1@jh.edu |
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| ID | Term |
|---|---|
| D010323 | Passive Cutaneous Anaphylaxis |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D012882 | Skin Tests |
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
|
| PRN fentanyl | Drug | IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU)) |
|
|
| Up to 16 hours |
| Morad A, Winters B, Stevens R, White E, Weingart J, Yaster M, Gottschalk A. The efficacy of intravenous patient-controlled analgesia after intracranial surgery of the posterior fossa: a prospective, randomized controlled trial. Anesth Analg. 2012 Feb;114(2):416-23. doi: 10.1213/ANE.0b013e31823f0c5a. Epub 2011 Dec 9. |
| Unanticipated Neurosurgical Complication |
|
| Inability to trigger PCA |
|
| Unrecognized exclusion criteria met |
|
| BG001 | Supratentorial PRN Fentanyl | 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)) |
| BG002 | 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 |
| BG003 | 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)) |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | 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 |
| OG003 | 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)) |
|
|
| Secondary | Fentanyl Consumption | 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. | Posted | Mean | Standard Deviation | mcg/hour | Up to 16 hours |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | 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)) | 0 | 35 | 0 | 35 | 0 | 35 |
| EG002 | 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 | 0 | 31 | 0 | 31 | 0 | 31 |
| EG003 | 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)) | 0 | 34 | 0 | 34 | 0 | 34 |
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| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D000937 | Antigen-Antibody Reactions |
| D055633 | Immune System Phenomena |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |