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CompletedNCT03943199Updated Jul 30, 2019

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

An interventional study of Visual Analogue Scale for pain in Scorpion Stings, Pain and Analgesic, sponsored by Mexican Red Cross. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-30.

Sponsored by Mexican Red Cross · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Scorpion Stings
  • Pain
  • Analgesic

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In context

Bites and Stings

112 studies on the registry are indexed under Bites and Stings; 45 are open to participants now.

This study's enrollment of 160 is above the median of 60 across 89 interventional studies indexed under Bites and Stings.

Browse Bites and Stings studies →

Lead sponsor

Mexican Red Cross is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
160 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • Placebo comparator
    Placebo

    20 milliliters of 0.9% physiological solution, will be applied for 5 minutes.

    Diagnostic Test: Visual Analogue Scale for pain

Interventions

  • Diagnostic testVisual Analogue Scale for pain

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

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What researchers measure

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

    Time frame: 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.

    Comparison of the effectiveness inter group over the pain by scorpion sting by Visual Analog Scales (VAS) valued from 0 to 10

    Time frame: 0, 30, 60 and 90 minutes after administered the drug

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Study locations

1 site
  • Cruz Roja Mexicana, Delegación León
    León, Guanajuato 37179, Mexico
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03943199
Lead sponsor
Mexican Red Cross
Collaborators
Instituto Bioclon S.A. de C.V.
Responsible party
Josue Saul Almaraz Lira (Principal Investigator, Mexican Red Cross) — Principal investigator
First posted
May 9, 2019
Start date
May 5, 2019
Primary completion
Jul 5, 2019
Completion
Jul 20, 2019
Last update
Jul 30, 2019

Study contacts

Alfredo Luis H Chávez Haro
study director · Investigator
Josue Saul H Almaraz
principal investigator · Investigator

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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