A randomised double blind placebo controlled trial of the efficacy of prophylactic adrenaline in the prevention of adverse reactions to anti snake venom (ASV)
| ISRCTN | ISRCTN18411149 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18411149 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/09/2005
- Registration date
- 29/09/2005
- Last edited
- 15/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Joseph Joseph
Scientific
Scientific
Little Flower Hospital and Research Centre
Kalady Road
Angamaly Kerala
683572
India
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | |
| Study objectives | That subcutaneous prophylactic adrenaline reduces the number of adverse anti snake venom reactions |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Anaphylactoid or Pyrogenic reactions to anti snake venom |
| Intervention | Subcutaneous Adrenaline will be administered before ASV. Control: Placebo. All outcomes will be monitored. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Adrenaline |
| Primary outcome measure | Level of adverse reactions |
| Secondary outcome measures | Severity of reactions |
| Overall study start date | 01/10/2005 |
| Completion date | 01/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 250 |
| Key inclusion criteria | 1. Snakebite with systemic symptoms 2. Requirement for ASV 3. Consent |
| Key exclusion criteria | 1. Severe atopic diseases such as asthma 2. Acute cardiac conditions 3. Pregnant women and children <15 years |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 01/10/2008 |
Locations
Countries of recruitment
- India
Study participating centre
Little Flower Hospital and Research Centre
Angamaly Kerala
683572
India
683572
India
Sponsor information
Little Flower Hospital and Research Centre (India)
Hospital/treatment centre
Hospital/treatment centre
PB No. 23
Kalady Road
Angamaly Kerala
683572
India
| Website | http://www.lfsru.org |
|---|---|
"ROR" |
https://ror.org/0375jhj23 |
Funders
Funder type
Hospital/treatment centre
Little Flower Hospital (India)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
