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

Primary Purpose

Scorpion Stings, Pain, Analgesic

Status

Completed

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

Visual Analogue Scale for pain

About this trial

This is an interventional treatment trial for Scorpion Stings

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cruz Roja Mexicana, Delegación León

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Metamizole sodium

Ketorolac

Lysine Clonixinate

Placebo

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03943199

First Posted

May 6, 2019

Last Updated

July 29, 2019

Sponsor

Mexican Red Cross

Collaborators

Instituto Bioclon S.A. de C.V.

1. Study Identification

Unique Protocol Identification Number

NCT03943199

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

May 5, 2019 (Actual)

Primary Completion Date

July 5, 2019 (Actual)

Study Completion Date

July 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mexican Red Cross

Collaborators

Instituto Bioclon S.A. de C.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Scorpion Stings, Pain, Analgesic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Metamizole sodium

Arm Type

Active Comparator

Arm Description

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

Arm Title

Ketorolac

Arm Type

Active Comparator

Arm Description

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

Arm Title

Lysine Clonixinate

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Visual Analogue Scale for pain

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Comparison of venom metabolism in patients valued at 18 hours with Visual Analog Scales (VAS) valued from 0 to 10

Time Frame

18 hours after drugs in study

Secondary Outcome Measure Information:

Title

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

Description

Comparison of the effectiveness inter group over the pain by scorpion sting by Visual Analog Scales (VAS) valued from 0 to 10

Time Frame

0, 30, 60 and 90 minutes after administered the drug

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alfredo Luis H Chávez Haro

Organizational Affiliation

Investigator

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Josue Saul H Almaraz

Organizational Affiliation

Investigator

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cruz Roja Mexicana, Delegación León

City

León

State/Province

Guanajuato

ZIP/Postal Code

37179

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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