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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

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

Clinicaltrials.gov identifier NCT03943199

Recruitment Status Completed

First Posted May 9, 2019

Last update posted July 30, 2019

Study Description

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:Scorpion Stings
    Pain
    Analgesic
  • Intervention/Treatment: Diagnostic Test: Visual Analogue Scale for pain
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • 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 2019
  • Actual Primary Completion Date: July 2019
  • Actual Study Completion Date: July 2019
Arms and interventions
Arm Intervention/treatment
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.
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.
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.
Outcome Measures
  • 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
Eligibility Criteria
  • 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

Contacts and Locations
Contacts
Locations

Mexico, Guanajuato
Cruz Roja Mexicana, Delegación León
León

Sponsors and Collaborators

Mexican Red Cross

Instituto Bioclon S.A. de C.V.

Investigators

Study Director: Alfredo Luis H Chávez Haro Investigator

Principal Investigator: Josue Saul H Almaraz Investigator

More Information
  • Responsible Party: Mexican Red Cross
  • ClinicalTrials.gov Identifier: NCT03943199 History of Changes
  • 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
  • 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.: Yes
  • Additional relevant MeSH terms: Bites and Stings Scorpion Stings