Effect of Coolant Spray on Traumatic Rib Pain of Geriatric Patients

Sponsor

Ataturk University (Other)

Overall Status

Completed

CT.gov ID

NCT04937933

Collaborator

(none)

101

Enrollment

Location

Arms

Actual Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Thorax; Fracture Pain; Thorax, Thoracic, Spine, With Radicular and Visceral Pain	Drug: Coolant spray (Cryos ®Spray, Phyto Performance, Italy) Drug: Saline solution	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

101 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Oct 1, 2019

Actual Primary Completion Date :

Oct 1, 2020

Actual Study Completion Date :

Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Coolant spray group Coolant spray (Cryos ®Spray, Phyto Performance, Italy) 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.	Drug: Coolant spray (Cryos ®Spray, Phyto Performance, Italy) The coolant spray treatment method is a cryotherapy non-pharmacological treatment choice.
Placebo Comparator: Placebo group A standard saline solution in a bottle covered with opaque white paper and refrigerated at 4°C was prepared. Saline solution was sprayed for the same duration and at the same distance from the injured area as well like coolant spray application. 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.	Drug: Saline solution saline solution

Arm

Intervention/Treatment

Active Comparator: Coolant spray group

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

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

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

Placebo Comparator: Placebo group

A standard saline solution in a bottle covered with opaque white paper and refrigerated at 4°C was prepared. Saline solution was sprayed for the same duration and at the same distance from the injured area as well like coolant spray application. 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.

Drug: Saline solution

saline solution

Outcome Measures

Primary Outcome Measures

Pain level [6 hoursa]
The study's primary outcome is determined as a ≥50% reduction (clinical effectiveness) according to the initial VAS score

Secondary Outcome Measures

Rescure Medicine [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.