A Phase 2/3 interventional study of PCA fentanyl and PRN fentanyl in Intracranial Surgery, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-26.
Sponsored by Johns Hopkins University · Phase 2/3, Interventional, and Treatment
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.
Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: PCA fentanyl
Drug: PRN fentanyl
Drug: PCA fentanyl
Drug: PRN 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
Also known as: PCA
IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
Also known as: IV fentanyl
Hourly Pain Scores
Patients' Numerical Rating Scale scores (0-10: 0 = no pain, 10 = worst imaginable pain)
Time frame: Up to 16 hours
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.
Time frame: Up to 16 hours
| Milestone | Supratentorial PCA Fentanyl | Supratentorial PRN Fentanyl | Infratentorial PCA Fentanyl | Infratentorial PRN Fentanyl |
|---|---|---|---|---|
| Started | 39 | 40 | 40 | 40 |
| Completed | 29 | 35 | 31 | 34 |
| Not completed | 10 | 5 | 9 | 6 |
| Withdrew: Protocol violation | 2 | 1 | 6 | 4 |
| Withdrew: Unanticipated neurosurgical complication | 6 | 3 | 3 | 2 |
| Withdrew: Inability to trigger pca | 2 | 0 | 0 | 0 |
| Withdrew: Unrecognized exclusion criteria met | 0 | 1 | 0 | 0 |
Patients' Numerical Rating Scale scores (0-10: 0 = no pain, 10 = worst imaginable pain)
| units on a scale | Supratentorial PCA Fentanyl | Supratentorial PRN Fentanyl | Infratentorial PCA Fentanyl | Infratentorial PRN Fentanyl |
|---|---|---|---|---|
| Hourly Pain Scores | 2.5 ± 2.0 | 3.6 ± 2.1 | 3.7 ± 1.9 | 5.2 ± 1.9 |
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.
| mcg/hour | Supratentorial PCA Fentanyl | Supratentorial PRN Fentanyl | Infratentorial PCA Fentanyl | Infratentorial PRN Fentanyl |
|---|---|---|---|---|
| Fentanyl Consumption | 44.1 ± 34.5 | 23.6 ± 23.7 | 54.8 ± 34.8 | 29.9 ± 16.4 |
Collected over Adverse events data were collected only during the time of patient enrollment in the study, up to 16 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Supratentorial PCA Fentanyl | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Supratentorial PRN Fentanyl | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Infratentorial PCA Fentanyl | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Infratentorial PRN Fentanyl | 0/34 (0%) | 0/34 (0%) | 0/34 (0%) |
| Age, Continuous(years) | Supratentorial PCA Fentanyl | Supratentorial PRN Fentanyl | Infratentorial PCA Fentanyl | Infratentorial PRN Fentanyl | Total |
|---|---|---|---|---|---|
| Mean | 48.2 ± 11.9 | 47.8 ± 15.0 | 45.4 ± 14.6 | 41.4 ± 11.1 | 45.6 ± 13.2 |
| Sex: Female, Male(Participants) | Supratentorial PCA Fentanyl | Supratentorial PRN Fentanyl | Infratentorial PCA Fentanyl | Infratentorial PRN Fentanyl | Total |
|---|---|---|---|---|---|
| Female | 18 | 17 | 20 | 21 | 76 |
| Male | 11 | 18 | 11 | 13 | 53 |
| Region of Enrollment(Participants) | Supratentorial PCA Fentanyl | Supratentorial PRN Fentanyl | Infratentorial PCA Fentanyl | Infratentorial PRN Fentanyl | Total |
|---|---|---|---|---|---|
| United States | 29 | 35 | 31 | 34 | 129 |
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Johns Hopkins University