Scorpion StingsNCT03943199
Comparison of Lysine Clonixinate, Ketorolac and Metamizole Sodium in Scorpion Stings
A study testing Visual Analogue Scale for pain in people with Scorpion Stings and Pain, run by Mexican Red Cross at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scorpion Stings, Pain, Analgesic
- What is being tested?
- Visual Analogue Scale for pain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteMexico
- Study dates
- 5 May 2019to 20 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial: Comparison of Lysine Clonixinate, Ketorolac and Metamizole Sodium in Poisoning by Scorpion Stings
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.
Read the 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.
- Conditions
- Scorpion Stings, Pain, Analgesic
- Being tested
- Visual Analogue Scale for pain
- Medical subject headings
- Scorpion Stings, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Analogue Scale for painDiagnostic test
Will be assessed at 0´, 30´, 60´, 90 minutes and 18 hours after the application of the analgesic.
| Study group | Role | What they receive |
|---|---|---|
| Metamizole sodium | Active comparator | 1 gram intravenous, will be diluted in 0.9% physiological solution of 100 ml, applied for 30 minutes Receives: Diagnostic Test: Visual Analogue Scale for pain |
| Ketorolac | Active comparator | 60 milligrams intravenously, it will be added to 20 ml with 0.9% physiological solution, it will be applied for 5 minutes Receives: Diagnostic Test: Visual Analogue Scale for pain |
| Lysine Clonixinate | Active comparator | 100 milligram intravenously, diluted in 5% glucose solution of 100 ml, applied for 30 minutes Receives: Diagnostic Test: Visual Analogue Scale for pain |
| Placebo | Placebo comparator | 20 milliliters of 0.9% physiological solution, will be applied for 5 minutes. Receives: Diagnostic Test: Visual Analogue Scale for pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 hours after drugs in study
Secondary outcomes (1)
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
Measured: 0, 30, 60 and 90 minutes after administered the drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start5 May 2019
- Primary completion5 Jul 2019
- Study completion20 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scorpion StingsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mexican Red Cross
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Bioclon S.A. de C.V.
- Responsible party
- Principal investigator, Josue Saul Almaraz Lira, Mexican Red Cross
- Investigators
- Alfredo Luis H Chávez Haro, Study director, InvestigatorJosue Saul H Almaraz, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943199
- Sponsor's protocol ID
- CRM-Alacran-2019
- Status last verified
- Jul 2019
- First submitted
- 6 May 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial: Comparison of Lysine Clonixinate, Ketorolac and Metamizole Sodium in Poisoning by Scorpion Stings
- ClinicalTrials.gov ID
- NCT03943199
- Acronym / sponsor ID
- CRM-Alacran-2019
- Conditions
- Scorpion Stings, Pain, Analgesic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Mexican Red CrossUniversity, hospital or other
- Collaborators
- Instituto Bioclon S.A. de C.V.
- Study start
- 5 May 2019 (actual)
- Primary completion
- 5 Jul 2019 (actual)
- Study completion
- 20 Jul 2019 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Metamizole sodium | Active comparator | Diagnostic Test: Visual Analogue Scale for pain1 gram intravenous, will be diluted in 0.9% physiological solution of 100 ml, applied for 30 minutes |
| Ketorolac | Active comparator | Diagnostic Test: Visual Analogue Scale for pain60 milligrams intravenously, it will be added to 20 ml with 0.9% physiological solution, it will be applied for 5 minutes |
| Lysine Clonixinate | Active comparator | Diagnostic Test: Visual Analogue Scale for pain100 milligram intravenously, diluted in 5% glucose solution of 100 ml, applied for 30 minutes |
| Placebo | Placebo comparator | Diagnostic Test: Visual Analogue Scale for pain20 milliliters of 0.9% physiological solution, will be applied for 5 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual Analogue Scale for painWill be assessed at 0´, 30´, 60´, 90 minutes and 18 hours after the application of the analgesic. | Diagnostic test | Ketorolac, Lysine Clonixinate, Metamizole sodium, Placebo |
Primary outcome
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
1 secondary outcome
Evaluate the analgesic efficacy of clonixinate of lysine, ketorolac and sodium metamizol, by the visual analogue scale of pain in poisoning by scorpion stings.
Time frame: 0, 30, 60 and 90 minutes after administered the drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfredo Luis H Chávez Haro study director
Investigator
Josue Saul H Almaraz principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Analogue Scale for pain in people with Scorpion Stings and Pain, run by Mexican Red Cross at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.