A Phase 4 interventional study of adrenaline, promethazine, hydrocortisone in Snake Bites, sponsored by University of Kelaniya. Completed at 1 site in Sri Lanka. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2008-06-05.
Sponsored by University of Kelaniya · Phase 4, Interventional, and Treatment
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.
38 studies on the registry are indexed under Snake Bites; 11 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 70 across 18 interventional studies indexed under Snake Bites.
Browse Snake Bites studies →University of Kelaniya is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug pages: Epinephrine · Promethazine · Hydrocortisone
Frequency of severe reactions to antivenom in the first 48 hours
Frequency of moderate & severe reactions to antivenom in the first 48 hours
The record gives a start of Mar 2005, a primary completion of Apr 2008 and a completion of Apr 2008. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Epinephrine · Promethazine · Hydrocortisone
University of Kelaniya