Randomized Clinical Trial: Comparison of Lysine Clonixinate, Ketorolac and Metamizole Sodium in Poisoning by Scorpion Stings
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- Evaluate the efficacy of antivenom as a pain treatment by the visual analogue scale of pain in poisoning by scorpion stings.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Metamizole sodium
1 gram intravenous, will be diluted in 0.9% physiological solution of 100 ml, applied for 30 minutes
Intervention: Visual Analogue Scale for pain (Diagnostic Test)
Ketorolac
60 milligrams intravenously, it will be added to 20 ml with 0.9% physiological solution, it will be applied for 5 minutes
Intervention: Visual Analogue Scale for pain (Diagnostic Test)
Lysine Clonixinate
100 milligram intravenously, diluted in 5% glucose solution of 100 ml, applied for 30 minutes
Intervention: Visual Analogue Scale for pain (Diagnostic Test)
Placebo
20 milliliters of 0.9% physiological solution, will be applied for 5 minutes.
Intervention: Visual Analogue Scale for pain (Diagnostic Test)
Outcomes
Primary Outcomes
Evaluate the efficacy of antivenom as a pain treatment by the visual analogue scale of pain in poisoning by scorpion stings.
Time Frame: 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 Outcomes
- 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)
Investigators
Josue Saul Almaraz Lira
Principal Investigator
Mexican Red Cross