Establishment of Natural History of Scorpion Envenomation
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||Establishment of Natural History of Scorpion Envenomation in the Absence of Antivenom Treatment in Pediatric Patients|
- 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) [ Time Frame: 4 hours or discharge ] [ Designated as safety issue: No ]
- To characterize treatment in the absence of antivenom (total dose, maximum rate per hour and duration of use of midazolam) [ Time Frame: 4 hours or discharge ] [ Designated as safety issue: No ]
|Study Start Date:||August 2004|
|Study Completion Date:||July 2005|
|Primary Completion Date:||August 2004 (Final data collection date for primary outcome measure)|
Patients from the identified scorpion envenomation cases, who met inclusion/exclusion criteria.
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696683
|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|