Analgesic Use for Pain Relief in Scorpion Sting

NCT ID: NCT05125796

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-10-01

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.

Conditions

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Scorpion Stings

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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paracetamol

1000 mg intravenous paracetamol

Group Type ACTIVE_COMPARATOR

paracetamol

Intervention Type DRUG

1000 mg intravenous paracetamol in 100 mL normal saline

Dexketoprofen Trometamol

50 mg intravenous Dexketoprofen Trometamol

Group Type EXPERIMENTAL

Dexketoprofen Trometamol

Intervention Type DRUG

50 mg intravenous dexketoprofen Trometamol in 100 mL normal saline

topical lidocaine

%5 lidocaine 5 gr topical

Group Type EXPERIMENTAL

Lidocaine topical

Intervention Type DRUG

Application of 5 gr of 5% topical lidocaine

placebo

100 mL intravenous normal saline+ placebo topical pomade

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

100 mL intravenous normal saline infusion+ placebo topical pomade application

Interventions

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paracetamol

1000 mg intravenous paracetamol in 100 mL normal saline

Intervention Type DRUG

Dexketoprofen Trometamol

50 mg intravenous dexketoprofen Trometamol in 100 mL normal saline

Intervention Type DRUG

Lidocaine topical

Application of 5 gr of 5% topical lidocaine

Intervention Type DRUG

Placebo

100 mL intravenous normal saline infusion+ placebo topical pomade application

Intervention Type DRUG

Other Intervention Names

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Paracerol (paracetamol) Revafen(Dexketoprofen Trometamol) Anestol pomade(lidocaine) Placebo(intravenous normal saline+placebo topical pomade)

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adiyaman University Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Umut Gulacti

Adiyaman University Medical Faculty of Research and Training Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Umut Gülaçtı

Role: PRINCIPAL_INVESTIGATOR

Adiyaman University of Medical Faculty

Locations

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Adiyaman University Research Hospital

Adıyaman, Central, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2019-5-1

Identifier Type: -

Identifier Source: org_study_id

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