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Completed

NCT Number: NCT05500677

Lidocaine Spray for Pain Control in Rib Fractures

In this study, we aimed to compare the analgesic efficacy of lidocaine spray with tramadol hydrochloride and fentanyl citrate in rib fractures.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ankara City Hospital

Ankara, Turkey (Türkiye)

About this study

Patients over the age of 18 who came to our emergency department with blunt chest trauma were divided into three groups. Groups was created from patients who were given lidocaine 10% spray (local), i.v. 100 mg of tramadol and i.v. fentanyl 50 mcg. A total of 48 patients, each of whom were 16, were included in the study. Numerical rating scale (NRS) pain scores of the patients at baseline, 15th, 30th and 60th minutes were compared. These scores and the amount of falls at follow-up were analyzed comparatively between the 3 groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Open conscious
  • Oriented and cooperative
  • Blunt thoracic trauma and rib fracture
  • Numerical rating scale (NRS) was 5 or higher

Exclusion criteria

  • Patients who refused to participate in the study
  • Detected or suspected pregnancy
  • Known history of allergy or other adverse reaction to the drugs used in the study
  • History of sedative drug use or drug addiction
  • Analgesic use within 6 hours of admission to the emergency department
  • Needed emergency tube thoracostomy or surgical intervention
  • Hemodynamically unstable
  • Open and/or infected wounds in the fracture area

Treatment and study plan

Lidocaine topical

Drug

Lidocaine spray, which is a quick and easy-to-use topical local anesthetic, will be applied as a puff to the painful area.

Other names: Tramadol hydrochloride, Fentanyl citrate

Primary outcomes

  1. Pain control

    Time frame: 60th minutes.

    We use Numeric rating scala.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Comparison of the Analgesic Efficacy of Lidocaine Spray Versus Tramadol and Fentanyl for Pain Control in Rib Fractures: A Prospective, Randomized, Controlled and Open-label Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 15, 2022
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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