Analgesic Use for Pain Relief in Scorpion Sting

Scorpion Stings Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05125796
• Other study ID #: 2019-5-1
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: February 2024
• Source: Adiyaman University Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Bites and Stings
• Scorpion Stings

Intervention

Drug:
• paracetamol
1000 mg intravenous paracetamol in 100 mL normal saline
• Dexketoprofen Trometamol
50 mg intravenous dexketoprofen Trometamol in 100 mL normal saline
• Lidocaine topical
Application of 5 gr of 5% topical lidocaine
• Placebo
100 mL intravenous normal saline infusion+ placebo topical pomade application

Locations

Country	Name	City	State
Turkey	Adiyaman University Research Hospital	Adiyaman	Central

Sponsors (1)

Lead Sponsor	Collaborator
Adiyaman University Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse events	60 minutes after the study drug administered	60 minutes after the study drug administered
Secondary	need to rescue medication	60 minutes after the study drug administered	60 minutes after the study drug administered