Improving Safety of Antivenom in People Bitten by Snakes
Completed
University of Kelaniya
Phase 4
2005-03-01
A study to increase the safety of polyvalent antivenom involving 1000 patients in three
centres: low dose adrenaline, promethazine, & hydrocortisone (alone and in combination) to
prevent acute adverse reactions to antivenom in people bitten by snakes: randomised, double
blind, placebo-controlled trial.
Three hundred consecutive adult patients presenting to the emergency services of the
department of psychiatry and who are diagnosed by the treating doctor to be needing
tranquillization to control agitated or aggressive behavior will be randomized to receive
either Injection Olanzepine I.M. or Injection Haloperidol 10mg + Injection Promethazine 50
mg in this parallel group, block randomized, centrally-randomzed, allocation-concealed,
assessor-blinded pragmatic clinical trial.
The main outcome measure that the two treatments would be compared on would be the clinical
state of the patient 4 hours after intervention, but the rate of tranquillization, degree of
sedation, proportions tranquil and / or asleep at 15, 30, 60 and 240 minutes, need for
additional medication, use of physical restraints, doctors called back, numbers absconding
and adverse effects at each of these time points would also be compared. Compliance with
oral medication and adverse effects at the end of 2 weeks would also be compared.
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