Thorax; FracturePhase 4NCT04937933
Effect of Coolant Spray on Traumatic Rib Pain of Geriatric Patients
A Phase 4 study testing Coolant spray (Cryos ®Spray, Phyto Performance, Italy) and Saline solution in people with Thorax; Fracture and Pain; Thorax, Thoracic, Spine, With Radicular and Visceral Pain, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Thorax; Fracture, Pain; Thorax, Thoracic, Spine, With Radicular and Visceral Pain
- What is being tested?
- Coolant spray (Cryos ®Spray, Phyto Performance, Italy) and Saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 1 Nov 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Coolant Spray on Rib Fracture Pain of Geriatric Blunt Thoracic Trauma Patients: a Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Coolant spray (Cryos ®Spray, Phyto Performance, Italy), Saline solution
- Keywords
- Rib fracture, Geriatrics, Coolant Spray, Lidocaine
- Medical subject headings
- Fractures, Bone, Pain, Visceral Pain, Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coolant spray (Cryos ®Spray, Phyto Performance, Italy)Drug
The coolant spray treatment method is a cryotherapy non-pharmacological treatment choice.
Saline solutionDrug
saline solution
| Study group | Role | What they receive |
|---|---|---|
| Coolant spray group | Active comparator | 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. Receives: Drug: Coolant spray (Cryos ®Spray, Phyto Performance, Italy) |
| Placebo group | Placebo comparator | 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. Receives: Drug: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
The study's primary outcome is determined as a ≥50% reduction (clinical effectiveness) according to the initial VAS score
Measured: 6 hoursa
Secondary outcomes (1)
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.
Measured: 6 Hourss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start1 Oct 2019
- Primary completion1 Oct 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Thorax; FractureStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Osman KOCAK, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937933
- Sponsor's protocol ID
- Ataturk University00001
- Status last verified
- Jun 2021
- First submitted
- 17 Jun 2021
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29411048Gur 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.
PubMed 31973934Farion 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.
PubMed 18591524Waterhouse 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.
PubMed 23283254Zhu 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.
PubMed 30253890
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Coolant Spray on Rib Fracture Pain of Geriatric Blunt Thoracic Trauma Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04937933
- Acronym / sponsor ID
- Ataturk University00001
- Keywords
- Rib fracture, Geriatrics, Coolant Spray, Lidocaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coolant spray group | Active comparator | Drug: Coolant spray (Cryos ®Spray, Phyto Performance, Italy)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. |
| Placebo group | Placebo comparator | Drug: Saline solutionA 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coolant spray (Cryos ®Spray, Phyto Performance, Italy)The coolant spray treatment method is a cryotherapy non-pharmacological treatment choice. | Drug | Coolant spray group |
| Saline solutionsaline solution | Drug | Placebo group |
Primary outcome
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
1 secondary outcome
Rescure Medicine
Time frame: 6 Hourss
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Background: PubMed 29411048Peek 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.
- Background: PubMed 31973934Gur 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.
- Background: PubMed 18591524Farion 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.
- Background: PubMed 23283254Waterhouse 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.
- Background: PubMed 30253890Zhu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coolant spray (Cryos ®Spray, Phyto Performance, Italy) and Saline solution in people with Thorax; Fracture and Pain; Thorax, Thoracic, Spine, With Radicular and Visceral Pain, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: 6 hoursa). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04937933, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.