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Completed

NCT Number: NCT04937933

Effect of Coolant Spray on Traumatic Rib Pain of Geriatric Patients

This study aims to evaluate the effectiveness of cryotherapy in the early period pain treatment of elderly patients with rib fractures due to blunt thoracic trauma.In this prospective randomized controlled study, geriatric patients were assigned to groups to receive either coolant spray (n=51) or placebo spray (n=50). To the coolant spray group patients,a coolant spray was applied. To the placebo group patients, a normal saline solution in a bottle covered with white opaque paper and refrigerated at 4 °C was sprayed. The visual analog scale (VAS) scores of all patients were recorded before starting spray application (V 0 ), at 10th minute (V 1 ), 20th minute (V 2 ), 30th minute (V 3 ), 60th minute (V 4 ), 120th minute (V 5 ), and 360th minute (V 6 ). The mean decreases in the VAS scores and the mean of the percentage of reduction in the VAS scores were calculated.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ataturk University

Erzurum, Turkey (Türkiye)

About this study

The study was a prospective, randomized, controlled, double-blind, multicenter clinical trial.All patients were informed about the study procedures, and written consent was obtained from the volunteers, who agreed to participate. Application of the sprays and measurement of the VAS scores were performed by ED physicians who were blinded for the study. For the placebo group, a standard saline solution in a bottle covered with opaque white paper and refrigerated at 4°C was prepared. In the coolant spray group, coolant spray was applied as suggested by the manufacturer (at a distance of 20 cm from the injured area for 5-10 s). Saline solution was sprayed for the same duration and at the same distance from the injured area as well. The first spray application was performed after the initial assessment, and the second spray application was performed at the end of the 30th minute (immediately after the pain level/score measurement). All patients were given intravenous (IV) dexketoprofen (50 mg in 50 ml standard saline solution) in 5 minutes simultaneously with the first spray application. The physicians applied the designated treatment protocol for each treatment group. As a rescue analgesic treatment, patients were scheduled to be given IV fentanyl at a dose of 1 mcg/kg.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Trauma developed in less than 24 hours.
  • Presence of rib fractures below 3 (6).
  • Rib fractures being limited to a single hemithorax.
  • Having a visual analog scale (VAS) score of 5 or more.

Exclusion criteria

  • Inability to provide informed consent (altered mental state, non-Turkish-speaking).
  • Patients with chest injury scores above 11 were excluded from the study because of the insufficiency of this multimodal treatment.
  • Having additional trauma-related injuries (including lung contusion, pneumothorax, hemothorax, etc.), skin lesions at the site of trauma, and/or trauma-related pain in multiple regions of the thorax.
  • Patients with fractures in ribs 1 and 2 (in terms of the risk of serious injury that may accompany).
  • History of regular analgesic usage (such as chronic pain syndrome, rheumatoid arthritis, osteoarthritis), antiaggregant and anticoagulant drug usage, and/or allergy to nonsteroidal antiinflammatory drugs (NSAID) and narcotic analgesics.
  • History of having coagulation disorders, hematologic disease, gastrointestinal bleeding, uncontrolled heart failure, chronic renal failure, chronic liver failure, and chronic lung disease.
  • Patients in whom trauma-related complications developed during the ED follow-up, the general condition worsened, vital signs were unstable, and patients that needed to be hospitalized.

Treatment and study plan

Coolant spray (Cryos ®Spray, Phyto Performance, Italy)

Drug

The coolant spray treatment method is a cryotherapy non-pharmacological treatment choice.

Saline Solution

Drug

saline solution

Primary outcomes

  1. Pain level

    Time frame: 6 hoursa

    The study's primary outcome is determined as a ≥50% reduction (clinical effectiveness) according to the initial VAS score

Secondary outcomes

  1. Rescure Medicine

    Time frame: 6 Hourss

    The secondary outcome variable is the difference between the placebo and coolant spray groups in terms of the frequency of patients that needed at least one dose of rescue treatment during the study period.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

The Effect of Coolant Spray on Rib Fracture Pain of Geriatric Blunt Thoracic Trauma Patients: a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 24, 2021
Registry last updated
Jun 24, 2021

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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