Analgesic Use for Pain Relief in Scorpion Sting

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.

Study Overview

• Status: Completed
• Conditions: Scorpion Stings
• Intervention / Treatment: Drug: paracetamol; Drug: Dexketoprofen Trometamol; Drug: Lidocaine topical; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Central
    • Adıyaman, Central, Turkey, 02000
      • Adiyaman University Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Adiyaman University Research Hospital
• Investigators: Principal Investigator: Umut Gülaçtı, Adiyaman University of Medical Faculty

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: November 2, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Wounds and Injuries; Poisoning; Bites and Stings; Scorpion Stings; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Acetaminophen; Ketoprofen; Dexketoprofen trometamol
• Other Study ID Numbers: 2019-5-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No