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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Analgesic; Scorpion Stings
• Intervention / Treatment: Diagnostic test: Visual Analogue Scale for pain

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Guanajuato
    • León, Guanajuato, Mexico, 37179
      • Cruz Roja Mexicana, Delegación León

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	0, 30, 60 and 90 minutes after administered the drug

Collaborators and Investigators

• Sponsor: Mexican Red Cross
• Collaborators: Instituto Bioclon S.A. de C.V.
• Investigators: Study Director: Alfredo Luis H Chávez Haro, Investigator; Principal Investigator: Josue Saul H Almaraz, Investigator

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2019
• Primary Completion (Actual): July 5, 2019
• Study Completion (Actual): July 20, 2019

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Wounds and Injuries; Poisoning; Bites and Stings; Scorpion Stings
• Other Study ID Numbers: CRM-Alacran-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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