Trial intelligence / Profile preview

Adrenaline, Promethazine, & Hydrocortisone for Antivenom Reactions

NCT00270777Phase 4

Key facts

Status: Completed
Start: Mar 2005
Primary completion: Apr 2008
Countries: 1
Sponsor: University of Kelaniya
Modality: Recombinant Proteins and Enzymes, Small Molecules

Drugs: epinephrinepromethazinehydrocortisone
Conditions: snakebite

Overview

Phase 4, randomised, double-blind trial of epinephrine, promethazine and hydrocortisone in snakebite (8 arms), sponsored by University of Kelaniya. Primary endpoint: Frequency of severe reactions to antivenom at 48 hours. Started Mar 2005; status: completed.

Design

8 arms

Study design: RandomizedDouble-blind

Adrenaline
Adrenaline + Placebo P + Placebo H
Promethazine
Promethazine + Placebo A + Placebo H
Hydrocortisone
Hydrocortisone + Placebo A + Placebo P
Adrenaline + Promethazine
Adrenaline + Promethazine + Placebo H
Adrenaline + Hydrocortisone
Adrenaline + Hydrocortisone + Placebo P
Promethazine + Hydrocortisone
Promethazine + Hydrocortisone + Placebo A

2 more in the full profile.

Who it enrols

Patients above 12 years admitted for snake bite requiring antivenom. Excludes pregnant/nursing patients, those on beta/alpha blockers or tricyclics, and those with contraindications to adrenaline (ischemic heart disease, stroke, uncontrolled hypertension, tachyarrhythmias).

Endpoints

Primary

Frequency of severe reactions to antivenom48 hours

Secondary

Frequency of moderate & severe reactions to antivenom48 hours
Frequency of severe reactions to antivenom at 1 hour1 hour
Frequency of severe reactions to antivenom at 6 hours6 hours

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