N/A
Completed N=102
Phenobarbital for Acute Alcohol Withdrawal
Alcohol Withdrawal
Source: ClinicalTrials.gov NCT01184417 ↗
Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcomePrimary: Number of Patients Requiring Continuous Lorazepam Infusion — 2; 16 participants
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.
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 | — |
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. Informational only — not medical advice.