An interventional study of 10 mg/kg IV phenobarbital in 100 ml saline and placebo in Alcohol Withdrawal, sponsored by Jonathan Rosenson. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-03-09.
Sponsored by Jonathan Rosenson · Not applicable, Interventional, and Treatment
Intravenous phenobarbital in combination with a symptom-guided standardized lorazepam-based alcohol withdrawal protocol will be associated with decreased need for ICU admission, continuous lorazepam infusion and will not be associated with increased adverse events.
This is the only study on the registry with Jonathan Rosenson as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
10 mg/kg IV phenobarbital in 100 ml saline
Drug: 10 mg/kg IV phenobarbital in 100 ml saline
100 ml saline
Drug: placebo
10 mg/kg IV phenobarbital in 100 ml saline
100 m l saline
Number of Patients Requiring Continuous Lorazepam Infusion
All study patients are placed on the standardized institutional alcohol withdrawal protocol and receive boluses of lorazepam (1, 2 or 4 mg IV) based on their acute alcohol withdrawal score (AAWS), adminstered serially up to every 15 minutes. Patients who are refractory to the maximum dose of lorazepam allowed by the protocol (up to 4mg lorazepam IV q 15 mins)are placed on a continuous IV lorazepam infusion (or "lorazepam drip"). Thus, continuous lorazepam infusion is a "yes or no" variable (i.e. continuous infusion, or not).
Time frame: 1 year
Percentage of Patients Requiring ICU Admission
admission to intensive care unit
Time frame: 1 year
Total Lorazepam Required Per Patient Per Admission
How much total lorazepam did each study patient receive from inital presentation in the Emergency Department through their discharge from the hospital, in milligrams.
Time frame: 1 year
Length of Stay
hospital LOS, per patient, in hours from admission to discharge
Time frame: 1 year
Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability
The outome answeres the question "Did the study patient require endotracheal intubation, or not". This outcome investigates if the phenobarbital intervention is associted with increased incidence of respiratory depression and subsequent increased need for intubation.
Time frame: 1 year
Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability
Did the study patient require a Licensed Vocational Nurse (LVN) or other hospital staff to serve as a "bedside sitter" to observe the patient and provide additional safety supervision during any portion of their hospitalization.
Time frame: 1 year
Number of Study Patients With Seizure as a Measure of Safety and Tolerability
Did the study patient have a witnessed seizure during their hospitaliztion (yes/no).
Time frame: 1 year
Number of Study Patients With Mortality as a Measure of Safety and Tolerability
mortality in study patients
Time frame: 1 year
| Milestone | Phenobarbital Group | Placebo Group |
|---|---|---|
| Started | 51 | 51 |
| Completed | 51 | 51 |
| Not completed | 0 | 0 |
All study patients are placed on the standardized institutional alcohol withdrawal protocol and receive boluses of lorazepam (1, 2 or 4 mg IV) based on their acute alcohol withdrawal score (AAWS), adminstered serially up to every 15 minutes. Patients who are refractory to the maximum dose of lorazepam allowed by the protocol (up to 4mg lorazepam IV q 15 mins)are placed on a continuous IV lorazepam infusion (or "lorazepam drip"). Thus, continuous lorazepam infusion is a "yes or no" variable (i.e. continuous infusion, or not).
| participants | Phenobarbital Group | Placebo Group |
|---|---|---|
| Number of Patients Requiring Continuous Lorazepam Infusion | 2 | 16 |
admission to intensive care unit
| percentage of participants | Phenobarbital Group | Placebo Group |
|---|---|---|
| Percentage of Patients Requiring ICU Admission | 8 (4 to 32) | 25 (4 to 32) |
How much total lorazepam did each study patient receive from inital presentation in the Emergency Department through their discharge from the hospital, in milligrams.
| milligrams | Phenobarbital Group | Placebo Group |
|---|---|---|
| Total Lorazepam Required Per Patient Per Admission | 26 ± 45 | 49 ± 37 |
hospital LOS, per patient, in hours from admission to discharge
| hours | Phenobarbital Group | Placebo Group |
|---|---|---|
| Length of Stay | 76 (54 to 114) | 118 (47 to 190) |
The outome answeres the question "Did the study patient require endotracheal intubation, or not". This outcome investigates if the phenobarbital intervention is associted with increased incidence of respiratory depression and subsequent increased need for intubation.
| participants | Phenobarbital Group | Placebo Group |
|---|---|---|
| Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability | 0 | 0 |
Did the study patient require a Licensed Vocational Nurse (LVN) or other hospital staff to serve as a "bedside sitter" to observe the patient and provide additional safety supervision during any portion of their hospitalization.
| percentage of participants | Phenobarbital Group | Placebo Group |
|---|---|---|
| Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability | 28 (-11 to 23) | 22 (-11 to 23) |
Did the study patient have a witnessed seizure during their hospitaliztion (yes/no).
| participants | Phenobarbital Group | Placebo Group |
|---|---|---|
| Number of Study Patients With Seizure as a Measure of Safety and Tolerability | 1 | 2 |
mortality in study patients
| participants | Phenobarbital Group | Placebo Group |
|---|---|---|
| Number of Study Patients With Mortality as a Measure of Safety and Tolerability | 0 | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phenobarbital Group | — | 0/51 (0%) | 0/51 (0%) |
| Placebo Group | — | 0/51 (0%) | 0/51 (0%) |
| Age, Categorical(Participants) | Phenobarbital Group | Placebo Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 51 | 51 | 102 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Phenobarbital Group | Placebo Group | Total |
|---|---|---|---|
| Mean | 46 ± 12 | 48 ± 17 | 47 ± 14 |
| Sex: Female, Male(Participants) | Phenobarbital Group | Placebo Group | Total |
|---|---|---|---|
| Female | 46 | 45 | 91 |
| Male | 5 | 6 | 11 |
| Region of Enrollment(participants) | Phenobarbital Group | Placebo Group | Total |
|---|---|---|---|
| United States | 51 | 51 | 102 |
This study is completed, as verified in Mar 2012. 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.