NCT05125796

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

1.1 years

First QC Date

November 2, 2021

Last Update Submit

February 7, 2024

Conditions

Scorpion Stings

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Adverse events

    60 minutes after the study drug administered

  • need to rescue medication

    60 minutes after the study drug administered

Study Arms (4)

paracetamol

ACTIVE COMPARATOR

1000 mg intravenous paracetamol

Drug: paracetamol

Dexketoprofen Trometamol

EXPERIMENTAL

50 mg intravenous Dexketoprofen Trometamol

Drug: Dexketoprofen Trometamol

topical lidocaine

EXPERIMENTAL

%5 lidocaine 5 gr topical

Drug: Lidocaine topical

placebo

PLACEBO COMPARATOR

100 mL intravenous normal saline+ placebo topical pomade

Drug: Placebo

Interventions

paracetamolDRUG

1000 mg intravenous paracetamol in 100 mL normal saline

Also known as: Paracerol (paracetamol)
paracetamol
Dexketoprofen TrometamolDRUG

50 mg intravenous dexketoprofen Trometamol in 100 mL normal saline

Also known as: Revafen(Dexketoprofen Trometamol)
Dexketoprofen Trometamol
Lidocaine topicalDRUG

Application of 5 gr of 5% topical lidocaine

Also known as: Anestol pomade(lidocaine)
topical lidocaine
PlaceboDRUG

100 mL intravenous normal saline infusion+ placebo topical pomade application

Also known as: Placebo(intravenous normal saline+placebo topical pomade)
placebo

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 and over
  • Scorpion sting with pain
  • The diagnostic criteria of Grade 1 for Scorpion sting

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adiyaman University Research Hospital

Adıyaman, Central, 02000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scorpion Stings

Interventions

Acetaminophendexketoprofen trometamolLidocaine

Condition Hierarchy (Ancestors)

Bites and StingsPoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Umut Gülaçtı

    Adiyaman University of Medical Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adiyaman University Medical Faculty of Research and Training Hospital

Study Record Dates

First Submitted

November 2, 2021

First Posted

November 18, 2021

Study Start

September 1, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

February 8, 2024

Record last verified: 2024-02

Locations

TU(1)