N/A
N=102
Phenobarbital for Acute Alcohol Withdrawal
Alcohol Withdrawal
Bottom Line
View on ClinicalTrials.gov: NCT01184417 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Number of Patients Requiring Continuous Lorazepam Infusion — 2; 16 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 10 mg/kg IV phenobarbital in 100 ml saline (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jonathan Rosenson
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Requiring Continuous Lorazepam Infusion |
2; 16 | — |
| PRIMARY Percentage of Patients Requiring ICU Admission |
8; 25 | — |
| PRIMARY Total Lorazepam Required Per Patient Per Admission |
26; 49 | — |
| SECONDARY Length of Stay |
76; 118 | — |
| SECONDARY Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability |
0; 0 | — |
| SECONDARY Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability |
28; 22 | — |
| SECONDARY Number of Study Patients With Seizure as a Measure of Safety and Tolerability |
1; 2 | — |
| SECONDARY Number of Study Patients With Mortality as a Measure of Safety and Tolerability |
0; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Need for admission to hospital for acute alcohol withdrawal
Exclusion Criteria
- allergy to phenobarbital, lorazepam, age 65
Data sourced from ClinicalTrials.gov (NCT01184417). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.