NCT00696683

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2004

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2008

Completed
Last Updated

June 13, 2008

Status Verified

June 1, 2008

Enrollment Period

Same day

First QC Date

June 11, 2008

Last Update Submit

June 11, 2008

Conditions

Keywords

scorpionstingenvenomationantivenom

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.

Other: None, this is an observational study

Interventions

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

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

Study Sites (1)

The University of Arizona Health Science Center & Tucson Medical Center

Tucson, Arizona, 210202, United States

Location

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Walter García, MD

    Instituto Bioclon

    STUDY CHAIR

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

Locations