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Analgesic Use for Pain Relief in Scorpion Sting

Sponsor
Adiyaman University Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05125796
Collaborator
(none)
106
Enrollment
1
Location
4
Arms
13
Actual Duration (Months)
8.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: paracetamol
  • Drug: Dexketoprofen Trometamol
  • Drug: Lidocaine topical
  • Drug: Placebo
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
106 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Comparison of iv Paracetamol, iv Dexketoprofen and Topical Lidocaine in Scorpion Sting: a Placebo Randomized Controlled Trial
Actual Study Start Date :
Sep 1, 2020
Actual Primary Completion Date :
Oct 1, 2021
Actual Study Completion Date :
Oct 1, 2021

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change of the intensity of pain [30 minutes and 60 minutes after the study drug administered]

      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

    1. Adverse events [60 minutes after the study drug administered]

      60 minutes after the study drug administered

    2. need to rescue medication [60 minutes after the study drug administered]

      60 minutes after the study drug administered

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Adiyaman University Research Hospital Adıyaman Central Turkey 02000

    Sponsors and Collaborators

    • Adiyaman University Research Hospital

    Investigators

    • Principal Investigator: Umut Gülaçtı, Adiyaman University of Medical Faculty

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Umut Gulacti, Adiyaman University Medical Faculty of Research and Training Hospital, Adiyaman University Research Hospital
    ClinicalTrials.gov Identifier:
    NCT05125796
    Other Study ID Numbers:
    • 2019-5-1
    First Posted:
    Nov 18, 2021
    Last Update Posted:
    Jun 22, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Bites and Stings
    Scorpion Stings
    Acetaminophen
    Dexketoprofen trometamol
    Ketoprofen
    Lidocaine

    Study Results

    No Results Posted as of Jun 22, 2022