Scorpion StingsNCT05125796
Analgesic Use for Pain Relief in Scorpion Sting
A study testing paracetamol, Dexketoprofen Trometamol and Lidocaine topical in people with Scorpion Stings, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In scorpion stings, patients mostly apply with the complaint of pain. Emergency physicians need to relieve this pain quickly. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Scorpion Stings
- What is being tested?
- paracetamol, Dexketoprofen Trometamol and Lidocaine topical
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 1 Oct 2021
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 and over
- Scorpion sting with pain
- The diagnostic criteria of Grade 1 for Scorpion sting
Who cannot join
- Patients who denied to give informed consent
- Taking analgesic treatment (ice application or drugs etc.) in the last 6 hours
- Any symptoms and findings of systemic toxicity of scorpion sting
- Pregnant women
- Hemodynamically unstable patients
- Known allergy to drugs of the study
- Patients with renal disease
- The cases that passed more than 6 hours after the bite
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adiyaman University Research Hospital
Adıyaman, Central, 02000
About this study
Official title: Comparison of iv Paracetamol, iv Dexketoprofen and Topical Lidocaine in Scorpion Sting: a Placebo Randomized Controlled Trial
In scorpion stings, patients mostly apply with the complaint of pain. Emergency physicians need to relieve this pain quickly.
Read the detailed description
Aim: In this study, the analgesic efficacy of intravenous (IV) paracetamol, IV dexketoprofen trometamol and topical lidocaine will be compared in patients presenting with pain after scorpion sting.
Methods: This study is a double-blind, randomized, placebo-controlled study conducted in a tertiary emergency department. Adult patients who applied to the study with no systemic findings after scorpion sting and especially with pain will be randomly assigned to one of 4 groups: IV paracetamol, IV dexketoprofen trometamol, topical lidocaine or placebo. In order to determine the intensity of pain, Visual Analog Pain Score (VAS) will be measured at the time of admission to the emergency department, at the 30th minute and at the 60th minute. Afterwards, the VAS score changes between the groups will be compared.
- Conditions
- Scorpion Stings
- Being tested
- paracetamol, Dexketoprofen Trometamol, Lidocaine topical, Placebo
- Medical subject headings
- Scorpion Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracetamolDrug
Also called Paracerol (paracetamol)
1000 mg intravenous paracetamol in 100 mL normal saline
Dexketoprofen TrometamolDrug
Also called Revafen(Dexketoprofen Trometamol)
50 mg intravenous dexketoprofen Trometamol in 100 mL normal saline
Lidocaine topicalDrug
Also called Anestol pomade(lidocaine)
Application of 5 gr of 5% topical lidocaine
PlaceboDrug
Also called Placebo(intravenous normal saline+placebo topical pomade)
100 mL intravenous normal saline infusion+ placebo topical pomade application
| Study group | Role | What they receive |
|---|---|---|
| paracetamol | Active comparator | 1000 mg intravenous paracetamol Receives: Drug: paracetamol |
| Dexketoprofen Trometamol | Experimental | 50 mg intravenous Dexketoprofen Trometamol Receives: Drug: Dexketoprofen Trometamol |
| topical lidocaine | Experimental | %5 lidocaine 5 gr topical Receives: Drug: Lidocaine topical |
| placebo | Placebo comparator | 100 mL intravenous normal saline+ placebo topical pomade Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the intensity of pain
Pain intense will be measured by 100 mm visual analog scale (Zero; no pain and 100 mm; the worst pain) after 30th and 60th minutes later after the study drug administered
Measured: 30 minutes and 60 minutes after the study drug administered
Secondary outcomes (2)
Adverse events
60 minutes after the study drug administered
Measured: 60 minutes after the study drug administered
need to rescue medication
60 minutes after the study drug administered
Measured: 60 minutes after the study drug administered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start1 Sep 2020
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umut Gulacti, Adiyaman University Research Hospital
- Investigators
- Umut Gülaçtı, Principal investigator, Adiyaman University of Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125796
- Sponsor's protocol ID
- 2019-5-1
- Status last verified
- Feb 2024
- First submitted
- 2 Nov 2021
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of iv Paracetamol, iv Dexketoprofen and Topical Lidocaine in Scorpion Sting: a Placebo Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05125796
- Acronym / sponsor ID
- 2019-5-1
- Conditions
- Scorpion Stings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 18 Nov 2021 (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.
In scorpion stings, patients mostly apply with the complaint of pain. Emergency physicians need to relieve this pain quickly.
Detailed description
Aim: In this study, the analgesic efficacy of intravenous (IV) paracetamol, IV dexketoprofen trometamol and topical lidocaine will be compared in patients presenting with pain after scorpion sting.
Methods: This study is a double-blind, randomized, placebo-controlled study conducted in a tertiary emergency department. Adult patients who applied to the study with no systemic findings after scorpion sting and especially with pain will be randomly assigned to one of 4 groups: IV paracetamol, IV dexketoprofen trometamol, topical lidocaine or placebo. In order to determine the intensity of pain, Visual Analog Pain Score (VAS) will be measured at the time of admission to the emergency department, at the 30th minute and at the 60th minute. Afterwards, the VAS score changes between the groups will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| paracetamol | Active comparator | Drug: paracetamol1000 mg intravenous paracetamol |
| Dexketoprofen Trometamol | Experimental | Drug: Dexketoprofen Trometamol50 mg intravenous Dexketoprofen Trometamol |
| topical lidocaine | Experimental | Drug: Lidocaine topical%5 lidocaine 5 gr topical |
| placebo | Placebo comparator | Drug: Placebo100 mL intravenous normal saline+ placebo topical pomade |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 and over
- Scorpion sting with pain
- The diagnostic criteria of Grade 1 for Scorpion sting
Key exclusion criteria (8 listed)
- Patients who denied to give informed consent
- Taking analgesic treatment (ice application or drugs etc.) in the last 6 hours
- Any symptoms and findings of systemic toxicity of scorpion sting
- Pregnant women
- Hemodynamically unstable patients
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 |
|---|---|---|
| paracetamolAlso: Paracerol (paracetamol)1000 mg intravenous paracetamol in 100 mL normal saline | Drug | paracetamol |
| Dexketoprofen TrometamolAlso: Revafen(Dexketoprofen Trometamol)50 mg intravenous dexketoprofen Trometamol in 100 mL normal saline | Drug | Dexketoprofen Trometamol |
| Lidocaine topicalAlso: Anestol pomade(lidocaine)Application of 5 gr of 5% topical lidocaine | Drug | topical lidocaine |
| PlaceboAlso: Placebo(intravenous normal saline+placebo topical pomade)100 mL intravenous normal saline infusion+ placebo topical pomade application | Drug | placebo |
Primary outcome
Change of the intensity of pain
Time frame: 30 minutes and 60 minutes after the study drug administered
Pain intense will be measured by 100 mm visual analog scale (Zero; no pain and 100 mm; the worst pain) after 30th and 60th minutes later after the study drug administered
2 secondary outcomes
Adverse events
Time frame: 60 minutes after the study drug administered
need to rescue medication
Time frame: 60 minutes after the study drug administered
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 8 Feb 2024.
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.
Umut Gülaçtı principal investigator
Adiyaman University of Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paracetamol, Dexketoprofen Trometamol and Lidocaine topical in people with Scorpion Stings, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 8 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 8 Feb 2024. 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 Turkey (Türkiye). 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?
Change of the intensity of pain (time frame: 30 minutes and 60 minutes after the study drug administered). 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 8 Feb 2024.