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Effect of Coolant Spray on Traumatic Rib Pain of Geriatric Patients

Primary Purpose

Thorax; Fracture, Pain; Thorax, Thoracic, Spine, With Radicular and Visceral Pain

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Coolant spray (Cryos ®Spray, Phyto Performance, Italy)
Saline solution
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Thorax; Fracture focused on measuring Rib fracture, Geriatrics, Coolant Spray, Lidocaine

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ataturk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Coolant spray group

Placebo group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rescure Medicine
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.

Full Information

First Posted
June 17, 2021
Last Updated
June 23, 2021
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT04937933
Brief Title
Effect of Coolant Spray on Traumatic Rib Pain of Geriatric Patients
Official Title
The Effect of Coolant Spray on Rib Fracture Pain of Geriatric Blunt Thoracic Trauma Patients: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thorax; Fracture, Pain; Thorax, Thoracic, Spine, With Radicular and Visceral Pain
Keywords
Rib fracture, Geriatrics, Coolant Spray, Lidocaine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coolant spray group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Coolant spray (Cryos ®Spray, Phyto Performance, Italy)
Intervention Description
The coolant spray treatment method is a cryotherapy non-pharmacological treatment choice.
Intervention Type
Drug
Intervention Name(s)
Saline solution
Intervention Description
saline solution
Primary Outcome Measure Information:
Title
Pain level
Description
The study's primary outcome is determined as a ≥50% reduction (clinical effectiveness) according to the initial VAS score
Time Frame
6 hoursa
Secondary Outcome Measure Information:
Title
Rescure Medicine
Description
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.
Time Frame
6 Hourss

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ataturk University
City
Erzurum
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29411048
Citation
Peek J, Smeeing DPJ, Hietbrink F, Houwert RM, Marsman M, de Jong MB. Comparison of analgesic interventions for traumatic rib fractures: a systematic review and meta-analysis. Eur J Trauma Emerg Surg. 2019 Aug;45(4):597-622. doi: 10.1007/s00068-018-0918-7. Epub 2018 Feb 6.
Results Reference
background
PubMed Identifier
31973934
Citation
Gur STA, Dogruyol S, Kocak AO, Akbas I, Tuncer K, Karabulut H, Cakir Z. Comparison of effectiveness coolant spray and placebo in patients with acute ankle trauma prospective randomized controlled trial. Am J Emerg Med. 2020 Jul;38(7):1458-1462. doi: 10.1016/j.ajem.2019.12.054. Epub 2020 Jan 7.
Results Reference
background
PubMed Identifier
18591524
Citation
Farion KJ, Splinter KL, Newhook K, Gaboury I, Splinter WM. The effect of vapocoolant spray on pain due to intravenous cannulation in children: a randomized controlled trial. CMAJ. 2008 Jul 1;179(1):31-6. doi: 10.1503/cmaj.070874.
Results Reference
background
PubMed Identifier
23283254
Citation
Waterhouse MR, Liu DR, Wang VJ. Cryotherapeutic topical analgesics for pediatric intravenous catheter placement: ice versus vapocoolant spray. Pediatr Emerg Care. 2013 Jan;29(1):8-12. doi: 10.1097/PEC.0b013e31827b214b.
Results Reference
background
PubMed Identifier
30253890
Citation
Zhu Y, Peng X, Wang S, Chen W, Liu C, Guo B, Zhao L, Gao Y, Wang K, Lou F. Vapocoolant spray versus placebo spray/no treatment for reducing pain from intravenous cannulation: A meta-analysis of randomized controlled trials. Am J Emerg Med. 2018 Nov;36(11):2085-2092. doi: 10.1016/j.ajem.2018.03.068. Epub 2018 Mar 27.
Results Reference
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Effect of Coolant Spray on Traumatic Rib Pain of Geriatric Patients

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