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Analgesic Use for Pain Relief in Scorpion Sting

Primary Purpose

Scorpion Stings

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

paracetamol

Dexketoprofen Trometamol

Lidocaine topical

Placebo

About this trial

This is an interventional treatment trial for Scorpion Stings

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Adiyaman University Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

paracetamol

Dexketoprofen Trometamol

topical lidocaine

placebo

Arm Description

1000 mg intravenous paracetamol

50 mg intravenous Dexketoprofen Trometamol

%5 lidocaine 5 gr topical

100 mL intravenous normal saline+ placebo topical pomade

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse events

60 minutes after the study drug administered

need to rescue medication

60 minutes after the study drug administered

Full Information

NCT ID

NCT05125796

First Posted

November 2, 2021

Last Updated

June 16, 2022

Sponsor

Adiyaman University Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05125796

Brief Title

Analgesic Use for Pain Relief in Scorpion Sting

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

October 1, 2021 (Actual)

Study Completion Date

October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Adiyaman University Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Scorpion Stings

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

106 (Actual)

8. Arms, Groups, and Interventions

Arm Title

paracetamol

Arm Type

Active Comparator

Arm Description

1000 mg intravenous paracetamol

Arm Title

Dexketoprofen Trometamol

Arm Type

Experimental

Arm Description

50 mg intravenous Dexketoprofen Trometamol

Arm Title

topical lidocaine

Arm Type

Experimental

Arm Description

%5 lidocaine 5 gr topical

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

100 mL intravenous normal saline+ placebo topical pomade

Intervention Type

Drug

Intervention Name(s)

paracetamol

Other Intervention Name(s)

Paracerol (paracetamol)

Intervention Description

1000 mg intravenous paracetamol in 100 mL normal saline

Intervention Type

Drug

Intervention Name(s)

Dexketoprofen Trometamol

Other Intervention Name(s)

Revafen(Dexketoprofen Trometamol)

Intervention Description

50 mg intravenous dexketoprofen Trometamol in 100 mL normal saline

Intervention Type

Drug

Intervention Name(s)

Lidocaine topical

Other Intervention Name(s)

Anestol pomade(lidocaine)

Intervention Description

Application of 5 gr of 5% topical lidocaine

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo(intravenous normal saline+placebo topical pomade)

Intervention Description

100 mL intravenous normal saline infusion+ placebo topical pomade application

Primary Outcome Measure Information:

Title

Change of the intensity of pain

Description

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

Time Frame

30 minutes and 60 minutes after the study drug administered

Secondary Outcome Measure Information:

Title

Adverse events

Description

60 minutes after the study drug administered

Time Frame

60 minutes after the study drug administered

Title

need to rescue medication

Description

60 minutes after the study drug administered

Time Frame

60 minutes after the study drug administered

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Umut Gülaçtı

Organizational Affiliation

Adiyaman University of Medical Faculty

Official's Role

Principal Investigator

Facility Information:

Facility Name

Adiyaman University Research Hospital

City

Adıyaman

State/Province

Central

ZIP/Postal Code

02000

Country

Turkey

12. IPD Sharing Statement

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Analgesic Use for Pain Relief in Scorpion Sting

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