Establishment of Natural History of Scorpion Envenomation
1 other identifier
observational
97
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2004
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 11, 2008
CompletedFirst Posted
Study publicly available on registry
June 13, 2008
CompletedJune 13, 2008
June 1, 2008
Same day
June 11, 2008
June 11, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of overall duration of clinically important signs of scorpion envenomation (Clinically important signs of envenomation were divided into those indicative of respiratory distress and those comprising pathological agitation)
4 hours or discharge
Secondary Outcomes (1)
To characterize treatment in the absence of antivenom (total dose, maximum rate per hour and duration of use of midazolam)
4 hours or discharge
Study Arms (1)
A
Patients from the identified scorpion envenomation cases, who met inclusion/exclusion criteria.
Interventions
Eligibility Criteria
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.
You may qualify if:
- Males and females 6 months to 18 years of age
- Presenting for emergency treatment with clinically important systemic signs of scorpion sting envenomation
You may not qualify if:
- Use of any antivenom within the last month or concomitantly
- Signs and symptoms confined to local sting site
- Concurrent medical condition involving a baseline neurologic status mimicking envenomation (chorea, tardive dyskinesia, uncontrolled epilepsy)
- Incomplete or unavailable medical record
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Instituto Bioclon S.A. de C.V.lead
- University of Arizonacollaborator
Study Sites (1)
The University of Arizona Health Science Center & Tucson Medical Center
Tucson, Arizona, 210202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Walter García, MD
Instituto Bioclon
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 11, 2008
First Posted
June 13, 2008
Study Start
August 1, 2004
Primary Completion
August 1, 2004
Study Completion
July 1, 2005
Last Updated
June 13, 2008
Record last verified: 2008-06