Cryo-Analgesia versus Vibro-analgesia for Reducing Arterial Puncture Associated Pain: A Randomised Cross-over Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Pain measured using the NRS 11 Point Score at the time of arterial
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Pain measured using the NRS 11 Point Score at the time of arterial
时间窗: Immediately 5 minutes after application of intervention(vibration/gel ice pack application. | Minimum duration between both interventions is 4 hrs.
puncture
时间窗: Immediately 5 minutes after application of intervention(vibration/gel ice pack application. | Minimum duration between both interventions is 4 hrs.
次要结局
- (a) Number of attempts to gain an arterial blood sample((b)Memory of pain (1st & 2nd Prick) after 12 hours on VAS score)
研究者
Dr Chitra
All India Institute Of Medical Sciences, Bhopal