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

Not Applicable

Completed

• Conditions: Pain; Scorpion Stings; Analgesic
• Interventions: Diagnostic Test: Visual Analogue Scale for pain

• Registration Number: NCT03943199
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-05-05
• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-09
• Status Verified: 2019-07
• Primary Completion: 2019-07-05
• Study Completion: 2019-07-20
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Metamizole sodium	Visual Analogue Scale for pain	1 gram intravenous, will be diluted in 0.9% physiological solution of 100 ml, applied for 30 minutes
Placebo	Visual Analogue Scale for pain	20 milliliters of 0.9% physiological solution, will be applied for 5 minutes.
Lysine Clonixinate	Visual Analogue Scale for pain	100 milligram intravenously, diluted in 5% glucose solution of 100 ml, applied for 30 minutes
Ketorolac	Visual Analogue Scale for pain	60 milligrams intravenously, it will be added to 20 ml with 0.9% physiological solution, it will be applied for 5 minutes

Primary Outcome Measures

Name	Time	Method
Evaluate the efficacy of antivenom as a pain treatment by the visual analogue scale of pain in poisoning by scorpion stings.	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

Name	Time	Method
Evaluate the analgesic efficacy of clonixinate of lysine, ketorolac and sodium metamizol, by the visual analogue scale of pain in poisoning by scorpion stings.	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

Trial Locations

Locations (1)

Cruz Roja Mexicana, Delegación León; 🇲🇽 León, Guanajuato, Mexico