Effect of Coolant Spray on Traumatic Rib Pain of Geriatric Patients

NCT04937933 | Completed Phase 4

• 1 other identifier: Ataturk University00001
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Rib fracture; Geriatrics; Coolant Spray; Lidocaine

Outcome Measures

Primary Outcomes (1)

• Pain level

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

  6 hoursa

Secondary Outcomes (1)

• Rescure Medicine

  6 Hourss

Study Arms (2)

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.

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.

Drug: Saline solution

Interventions

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

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

Coolant spray group

Saline solution DRUG

saline solution

Placebo group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 29411048 BACKGROUND

• 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.

  PMID: 31973934 BACKGROUND

• 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.

  PMID: 18591524 BACKGROUND

• 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.

  PMID: 23283254 BACKGROUND

• 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.

  PMID: 30253890 BACKGROUND

MeSH Terms

Conditions

Fractures, Bone; Pain; Visceral Pain; Rib Fractures

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nociceptive Pain; Thoracic Injuries

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Emergency Department of Ataturk University

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 24, 2021
• Study Start: October 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: November 1, 2020
• Last Updated: June 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)