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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03943199
• Other study ID #: CRM-Alacran-2019
• Status: Completed
• Phase: N/A
• Start date: May 5, 2019
• Est. completion date: July 20, 2019

Study information

• Verified date: July 2019
• Source: Mexican Red Cross
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 20, 2019
• Est. primary completion date: July 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesic
• Bites and Stings
• Pain
• Scorpion Stings

Intervention

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.

Locations

Country	Name	City	State
Mexico	Cruz Roja Mexicana, Delegación León	León	Guanajuato

Sponsors (2)

Lead Sponsor	Collaborator
Mexican Red Cross	Instituto Bioclon S.A. de C.V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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