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Comparison of Lysine Clonixinate, Ketorolac and Metamizole Sodium in Scorpion Stings

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ClinicalTrials.gov Identifier: NCT03943199
Recruitment Status : Completed
First Posted : May 9, 2019
Last Update Posted : July 30, 2019
Sponsor:
Collaborator:
Instituto Bioclon S.A. de C.V.
Information provided by (Responsible Party):
Josue Saul Almaraz Lira, Mexican Red Cross

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.

Condition or disease Intervention/treatment Phase
Scorpion Stings Pain Analgesic Diagnostic Test: Visual Analogue Scale for pain Not Applicable

Detailed Description:

The states with the highest incidence of cases in 2018 were Jalisco with 47370 bite reports, Guerrero with 40672 cases and Guanajuato with 40331, according to the national epidemiological surveillance system.

Due to the high affinity on ion channels, where a cystine inhibitor BmP01, it is directed to the nociceptive ion channel TRPV1 to produce pain.Pain has been reported to occur in approximately 97% of patients They are seen in the emergency room.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial: Comparison of Lysine Clonixinate, Ketorolac and Metamizole Sodium in Poisoning by Scorpion Stings
Actual Study Start Date : May 5, 2019
Actual Primary Completion Date : July 5, 2019
Actual Study Completion Date : July 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Poisoning

Arm Intervention/treatment
Active Comparator: Metamizole sodium
1 gram intravenous, will be diluted in 0.9% physiological solution of 100 ml, applied for 30 minutes
Diagnostic Test: Visual Analogue Scale for pain
Will be assessed at 0´, 30´, 60´, 90 minutes and 18 hours after the application of the analgesic.

Active Comparator: Ketorolac
60 milligrams intravenously, it will be added to 20 ml with 0.9% physiological solution, it will be applied for 5 minutes
Diagnostic Test: Visual Analogue Scale for pain
Will be assessed at 0´, 30´, 60´, 90 minutes and 18 hours after the application of the analgesic.

Active Comparator: Lysine Clonixinate
100 milligram intravenously, diluted in 5% glucose solution of 100 ml, applied for 30 minutes
Diagnostic Test: Visual Analogue Scale for pain
Will be assessed at 0´, 30´, 60´, 90 minutes and 18 hours after the application of the analgesic.

Placebo Comparator: Placebo
20 milliliters of 0.9% physiological solution, will be applied for 5 minutes.
Diagnostic Test: Visual Analogue Scale for pain
Will be assessed at 0´, 30´, 60´, 90 minutes and 18 hours after the application of the analgesic.




Primary Outcome Measures :
  1. Evaluate the efficacy of antivenom as a pain treatment by the visual analogue scale of pain in poisoning by scorpion stings. [ Time Frame: 18 hours after drugs in study ]
    Comparison of venom metabolism in patients valued at 18 hours with Visual Analog Scales (VAS) valued from 0 to 10


Secondary Outcome Measures :
  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. [ Time Frame: 0, 30, 60 and 90 minutes after administered the drug ]
    Comparison of the effectiveness inter group over the pain by scorpion sting by Visual Analog Scales (VAS) valued from 0 to 10



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943199


Locations
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Mexico
Cruz Roja Mexicana, Delegación León
León, Guanajuato, Mexico, 37179
Sponsors and Collaborators
Mexican Red Cross
Instituto Bioclon S.A. de C.V.
Investigators
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Study Director: Alfredo Luis H Chávez Haro Investigator
Principal Investigator: Josue Saul H Almaraz Investigator
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Responsible Party: Josue Saul Almaraz Lira, Principal Investigator, Mexican Red Cross
ClinicalTrials.gov Identifier: NCT03943199    
Other Study ID Numbers: CRM-Alacran-2019
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Bites and Stings
Scorpion Stings
Poisoning
Chemically-Induced Disorders
Wounds and Injuries