Blood Gas Analysis, Topical Analgesia
Conditions
Brief summary
The aim of this clinical trial is to evaluate the analgesic efficacy of lidocaine and diclofenac sprays to be administered before the procedure in cases admitted to the emergency department and requiring radial artery blood gas sampling by means of visual pain scale (VAS) and perfusion index in comparison with placebo. The main questions it aims to answer are: 1\. Is there a difference between the efficacy of two different sprays? 2. Is there a significant difference between the side effects of two different sprays? Researchers will compare diclofenac sodium, lidocain and placebo sprays. Treatments will; 1. be administered in same three spray bottles to ensure blinding in the groups. 2. Randomisation will be done by closed envelope method. 3. Numerical Pain Scale (NRS) will be used to evaluate the analgesic efficacy of the sprays. NRS scores will be recorded in both groups before starting blood gas sampling (baseline) and after blood gas sampling. 4. Any side effects due to medication will be recorded.
Interventions
DRUGDiclofenac
Group II: 5-6 puffs of topical 1% diclofenac spray will be applied before radial artery blood gas sampling.
DRUGLidocaine spray
Group I: 5-6 puffs of topical 10% lidocaine spray will be applied before radial artery blood gas sampling.
OTHERPlacebo
Group III: 5-6 puffs of topical 70% alcohol solution spray will be applied before radial artery blood gas sampling.
Sponsors
Haydarpasa Numune Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Topical treatments will be administered in 100 cc amber coloured glass spray bottles to ensure blinding in all three treatment groups. The bottles will be prepared by the responsible investigator and numbered with the number on the sealed envelope. Thus, it will be ensured that the treating staff and the patient will be blinded to the treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Being between the ages of 18-65. * Having clinical indication for radial artery blood gas sampling * Being conscious, co-operative and orientated * Those who approved the informed consent form
Exclusion criteria
* Being under 18 years of age. * Being pregnant or breastfeeding. * Not being conscious, co-operative and orientated (impaired consciousness) * Being used painkillers in the last 24 hours * Radial artery blood gas sampling on the same day (more than one application) * Presence of cardiac arrhythmia * Have a diagnosis of neuropathy (including diabetic neuropathy) * Having a diagnosis of anxiety and panic disorder * Using a sustained-release dermal analgesic patch (fentanyl) * Patient unable to comply with the visual analogue pain scale (VAS) due to language barrier * Presence of a condition such as dementia, etc. that may lead to a change in consciousness * Allergy to lidocaine or diclofenac
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain scores associated with radial artery blood gas sampling | Baseline perfusion index and baseline VAS will be measured and recorded. 10 minutes after blood gas sampling, perfusion index and VAS score will be recorded. | The primary outcome of the study was the change in pain associated with radial artery blood gas sampling. It is aimed to provide patient comfort with spray applications. Differences between the 3 groups in VAS scores related to the intervention will be analysed. |
Countries
Turkey (Türkiye)
Outcome results
None listed