Establishment of Natural History of Scorpion Envenomation

This study has been completed.
Sponsor:
Collaborator:
University of Arizona
Information provided by:
Instituto Bioclon S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT00696683
First received: June 11, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

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
Scorpion Sting Envenomation
Other: None, this is an observational study

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Instituto Bioclon S.A. de C.V.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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
A
Patients from the identified scorpion envenomation cases, who met inclusion/exclusion criteria.
Other: None, this is an observational study

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • Males and females 6 months to 18 years of age
  • Presenting for emergency treatment with clinically important systemic signs of scorpion sting envenomation

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696683

Locations
United States, Arizona
The University of Arizona Health Science Center & Tucson Medical Center
Tucson, Arizona, United States, 210202
Sponsors and Collaborators
Instituto Bioclon S.A. de C.V.
University of Arizona
Investigators
Study Chair: Walter García, MD Instituto Bioclon
  More Information

No publications provided

Responsible Party: Walter Garcia Ubbelohde MD/ Clinical Research Manager, Instituto Bioclon S.A de C.V.
ClinicalTrials.gov Identifier: NCT00696683     History of Changes
Other Study ID Numbers: AL-03/06
Study First Received: June 11, 2008
Last Updated: June 11, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Instituto Bioclon S.A. de C.V.:
scorpion
sting
envenomation
antivenom

Additional relevant MeSH terms:
Poisoning
Scorpion Stings
Bites and Stings
Chemically-Induced Disorders
Wounds and Injuries

ClinicalTrials.gov processed this record on October 22, 2014