Analgesic Use for Pain Relief in Scorpion Sting

Study Overview
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Brief Summary
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In scorpion stings, patients mostly apply with the complaint of pain. Emergency physicians need to relieve this pain quickly.

Detailed Description
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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.

Official Title
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Comparison of iv Paracetamol, iv Dexketoprofen and Topical Lidocaine in Scorpion Sting: a Placebo Randomized Controlled Trial

Conditions
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Scorpion Stings

Intervention / Treatment
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* Drug: paracetamol
* Drug: Dexketoprofen Trometamol
* Drug: Lidocaine topical
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 and over Scorpion sting with pain The diagnostic criteria of Grade 1 for Scorpion sting Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: paracetamol<br>1000 mg intravenous paracetamol | Drug: paracetamol<br>* 1000 mg intravenous paracetamol in 100 mL normal saline<br>* Other names: Paracerol (paracetamol);|
| Experimental: Dexketoprofen Trometamol<br>50 mg intravenous Dexketoprofen Trometamol | Drug: Dexketoprofen Trometamol<br>* 50 mg intravenous dexketoprofen Trometamol in 100 mL normal saline<br>* Other names: Revafen(Dexketoprofen Trometamol);|
| Experimental: topical lidocaine<br>%5 lidocaine 5 gr topical | Drug: Lidocaine topical<br>* Application of 5 gr of 5% topical lidocaine<br>* Other names: Anestol pomade(lidocaine);|
| Placebo Comparator: placebo<br>100 mL intravenous normal saline+ placebo topical pomade | Drug: Placebo<br>* 100 mL intravenous normal saline infusion+ placebo topical pomade application<br>* Other names: Placebo(intravenous normal saline+placebo topical pomade);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 minutes and 60 minutes after the study drug administered | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | 60 minutes after the study drug administered | 60 minutes after the study drug administered | 
| need to rescue medication | 60 minutes after the study drug administered | 60 minutes after the study drug administered |