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

NCT ID: NCT03943199

Last Updated: 2019-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-05

Study Completion Date

2019-07-20

Brief Summary

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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

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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.

Conditions

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Scorpion Stings Pain Analgesic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Metamizole sodium

1 gram intravenous, will be diluted in 0.9% physiological solution of 100 ml, applied for 30 minutes

Group Type ACTIVE_COMPARATOR

Visual Analogue Scale for pain

Intervention Type DIAGNOSTIC_TEST

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

Ketorolac

60 milligrams intravenously, it will be added to 20 ml with 0.9% physiological solution, it will be applied for 5 minutes

Group Type ACTIVE_COMPARATOR

Visual Analogue Scale for pain

Intervention Type DIAGNOSTIC_TEST

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

Lysine Clonixinate

100 milligram intravenously, diluted in 5% glucose solution of 100 ml, applied for 30 minutes

Group Type ACTIVE_COMPARATOR

Visual Analogue Scale for pain

Intervention Type DIAGNOSTIC_TEST

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Visual Analogue Scale for pain

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Visual Analogue Scale for pain

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Bioclon S.A. de C.V.

INDUSTRY

Sponsor Role collaborator

Mexican Red Cross

OTHER

Sponsor Role lead

Responsible Party

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Josue Saul Almaraz Lira

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alfredo Luis H Chávez Haro

Role: STUDY_DIRECTOR

Investigator

Josue Saul H Almaraz

Role: PRINCIPAL_INVESTIGATOR

Investigator

Locations

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Cruz Roja Mexicana, Delegación León

León, Guanajuato, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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CRM-Alacran-2019

Identifier Type: -

Identifier Source: org_study_id

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