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Completed

NCT Number: NCT03943199

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

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.

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Key information

Conditions

Scorpion Stings Analgesic Bites and Stings Chemically-Induced Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Poisoning Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cruz Roja Mexicana, Delegación León

León, Guanajuato, 37179, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Visual Analogue Scale for pain

Diagnostic Test

Will be assessed at 0´, 30´, 60´, 90 minutes and 18 hours after the application of the analgesic.

Primary outcomes

  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 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.

    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

Sponsors and collaborators

Lead sponsor

Mexican Red Cross

Other

Collaborators

  • Instituto Bioclon S.A. de C.V.

Registry information

Official study title

Randomized Clinical Trial: Comparison of Lysine Clonixinate, Ketorolac and Metamizole Sodium in Poisoning by Scorpion Stings

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 9, 2019
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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