Cryo-Analgesia versus Vibro-analgesia for Reducing Arterial Puncture Associated Pain: A Randomised Cross-over Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Pain measured using the NRS 11 Point Score at the time of arterial
Study Overview
Brief Summary
The methods of pain relief during arterial puncture include pharmacological (infiltration or topical application of local anaesthetics) and non-pharmacological techniques (cryo-analgesia or local anaesthetic infiltration may cause its own pain along with obscuring landmarks. Topical anaesthetic application is associated with vasoconstriction and lower success rate. The nonpharmacological techniques have not yet gained popularity because of unavailability and inadequate knowledge regarding their efficacy. The efficacy of cryo-analgesia and vibro-analgesia is attributed to the concept of gate control theory of pain.
The principle behind buzzy device ® is gate control theory of pain; alternatively cold stimulus triggers the descending noxious inhibitory controls , activating supraspinal modulation and increasing the overall pain threshold of the body. Many studies have been conducted with Buzzy devices for venipuncture pain, which have shown good results.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 95.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •18-65 years old patients admitted to the SICU/MICU for any indication b.
- •Patient should be requiring repeated (at least 2) arterial blood gas analysis for any indication (example repeated potassium measurement for ongoing correction) c.
- •Should be alert enough to respond and provide feedback for the procedure d.
- •Should have availability of upper limb (radial artery) for the procedure with viable collateral circulation e.
- •Able to understand either Hindi or English.
Exclusion Criteria
- •n Sedation b.
- •On Mechanical Ventilation c.
- •Peripheral Vascular Disease, pre- existing chronic pain / neuropathy d.
- •Radial puncture not possible e.
- •Significant edema in the limb f.
- •Not giving consent g.
- •Hypovolemic h.
- •Patient on high dose vasopressors, inotropic agents i.
- •Already in significant pain at the time of ABG j.
- •Opioid Dependent.
Outcomes
Primary Outcomes
Pain measured using the NRS 11 Point Score at the time of arterial
Time Frame: Immediately 5 minutes after application of intervention(vibration/gel ice pack application. | Minimum duration between both interventions is 4 hrs.
puncture
Time Frame: Immediately 5 minutes after application of intervention(vibration/gel ice pack application. | Minimum duration between both interventions is 4 hrs.
Secondary Outcomes
- (a) Number of attempts to gain an arterial blood sample((b)Memory of pain (1st & 2nd Prick) after 12 hours on VAS score)
Investigators
Dr Chitra
All India Institute Of Medical Sciences, Bhopal