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Sponsors and Collaborators: |
Instituto Bioclon S.A. de C.V. University of Arizona |
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Information provided by: | Instituto Bioclon S.A. de C.V. |
ClinicalTrials.gov Identifier: | NCT00696683 |
This retrospective study was conducted to collect data from approximately 100 patients from 6 months to 18 years of age who were stung by a scorpion but were not treated with antivenom. The study consisted of a review of hospital records of patients who were admitted for intensive care management of scorpion envenomation, at the only two hospitals in North America known to admit children routinely for scorpion sting management without antivenom. The standard of care consisted of symptomatic and supportive care, including airway maintenance, fluid and electrolyte support and, if necessary, sedation.
Condition | Intervention |
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Scorpion Sting Envenomation |
Other: None, this is an observational study |
Study Type: | Observational |
Study Design: | Case-Only, Retrospective |
Official Title: | Establishment of Natural History of Scorpion Envenomation in the Absence of Antivenom Treatment in Pediatric Patients |
Enrollment: | 97 |
Study Start Date: | August 2004 |
Study Completion Date: | July 2005 |
Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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A
Patients from the identified scorpion envenomation cases, who met inclusion/exclusion criteria.
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Other: None, this is an observational study |
The study objective was to document the clinical syndrome of scorpion envenomation in the absence of antivenom treatment in pediatric patients. This was done to establish historical control data on the time from sting to the time of resolution of signs of envenomation. These historical control data are intended to be used for comparison with Alacramyn treated patients in two prospective studies being conducted in Mexico and the U.S.for which a control population could not otherwise be established.
The total duration of clinically important systemic signs of envenomation was determined based upon overall investigator assessment of the last signs of any respiratory compromise, any pathological agitation or other indicator of continuing illness (e.g., continuing need for sedative administration).
To facilitate comparison of these historical data with prospective open label trials, periodic assessments of the overall presence or absence of clinically important signs was performed. Periodic assessments were also performed for each individual component indicator of respiratory compromise and of pathological agitation, when available.
A research nurse reviewed hospital discharge diagnoses for all pediatric charts coded for "scorpion sting". For these cases demographic, diagnostic, and therapeutic data were entered on the case report form (CRF) as well as data necessary to assess compliance with study inclusion and exclusion criteria.
A physician subinvestigator reviewed the research nurse's findings for the key outcome indicators, which consisted of clinically important systemic signs of scorpion envenomation and adjunctive sedation treatment (dose and timing of dose) when medical judgment was required.
Ages Eligible for Study: | 6 Months to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Male and female patients 6 months to 18 years of age who presented for emergency treatment of scorpion sting and who had clinically important systemic signs of envenomation were included.
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
The University of Arizona Health Science Center & Tucson Medical Center | |
Tucson, Arizona, United States, 210202 |
Study Chair: | Walter García, MD | Instituto Bioclon |
Responsible Party: | Instituto Bioclon S.A de C.V. ( Walter Garcia Ubbelohde MD/ Clinical Research Manager ) |
Study ID Numbers: | AL-03/06 |
Study First Received: | June 11, 2008 |
Last Updated: | June 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00696683 |
Health Authority: | United States: Food and Drug Administration |
scorpion sting envenomation antivenom |
Antivenins |