Comparison of Lysine Clonixinate, Ketorolac and Metamizole Sodium in Scorpion Stings
Randomized Clinical Trial: Comparison of Lysine Clonixinate, Ketorolac and Metamizole Sodium in Poisoning by Scorpion Stings
1 other identifier
interventional
160
1 country
1
Brief Summary
The cases of scorpion stings are matters of medical importance, where Mexico is considered as one of the main countries of such public health problem.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2019
Shorter than P25 for not_applicable
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
May 5, 2019
CompletedFirst Submitted
Initial submission to the registry
May 6, 2019
CompletedFirst Posted
Study publicly available on registry
May 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2019
CompletedJuly 30, 2019
July 1, 2019
2 months
May 6, 2019
July 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate the efficacy of antivenom as a pain treatment by the visual analogue scale of pain in poisoning by scorpion stings.
Comparison of venom metabolism in patients valued at 18 hours with Visual Analog Scales (VAS) valued from 0 to 10
18 hours after drugs in study
Secondary Outcomes (1)
Evaluate the analgesic efficacy of clonixinate of lysine, ketorolac and sodium metamizol, by the visual analogue scale of pain in poisoning by scorpion stings.
0, 30, 60 and 90 minutes after administered the drug
Study Arms (4)
Metamizole sodium
ACTIVE COMPARATOR1 gram intravenous, will be diluted in 0.9% physiological solution of 100 ml, applied for 30 minutes
Ketorolac
ACTIVE COMPARATOR60 milligrams intravenously, it will be added to 20 ml with 0.9% physiological solution, it will be applied for 5 minutes
Lysine Clonixinate
ACTIVE COMPARATOR100 milligram intravenously, diluted in 5% glucose solution of 100 ml, applied for 30 minutes
Placebo
PLACEBO COMPARATOR20 milliliters of 0.9% physiological solution, will be applied for 5 minutes.
Interventions
Will be assessed at 0´, 30´, 60´, 90 minutes and 18 hours after the application of the analgesic.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of pain by scorpion stings
- Patients\> 18 years old
- Clinical diagnosis of scorpion sting poisoning grade I, II and III.
- Chronic degenerative diseases (renal failure, hypertension, liver damage)
You may not qualify if:
- Patients who reject the continuation of medical treatment
- Patients who are transferred to a unit of second level of care.
- Patients with pharmacological treatment prior
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mexican Red Crosslead
- Instituto Bioclon S.A. de C.V.collaborator
Study Sites (1)
Cruz Roja Mexicana, Delegación León
León, Guanajuato, 37179, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alfredo Luis H Chávez Haro
Investigator
- PRINCIPAL INVESTIGATOR
Josue Saul H Almaraz
Investigator
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 6, 2019
First Posted
May 9, 2019
Study Start
May 5, 2019
Primary Completion
July 5, 2019
Study Completion
July 20, 2019
Last Updated
July 30, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share