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Safety and efficacy of intranasal ketamine for acute postoperative pain

机译:鼻内氯胺酮治疗急性术后疼痛的安全性和有效性

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Background: Subanaesthetic doses of ketamine are analgesic. Intranasal administration offers a non-invasive route for systemic drug delivery. We evaluated the safety and analgesic efficacy of intranasal ketamine in treating moderate-to-severe, acute postoperative pain in the molar extraction model. Methods: Intranasal ketamine (10 mg, 30 mg, and 50 mg) and placebo were evaluated in a randomised, double-blind, single-dose, parallel study in 40 patients undergoing removal of 2-4 impacted third molars. Analgesic efficacy was assessed over a 3 h period following drug administration. Safety was evaluated through adverse event reporting, vital signs, pulse oximetry, nasal assessments, and a standard dissociative side effects questionnaire. Results: Ketamine delivered intranasally was well tolerated. Statistically significant analgesia, superior to placebo, was observed with the highest dose tested, 50 mg, over a 3h period. Rapid onset of analgesia was reported (<10min), and meaningful pain relief was achieved within 15min of the 50 mg dose. The majority of adverse events were mild/weak and transient. No untoward effects were observed on vital signs, pulse oximetry, and nasal examination. At the doses tested, no significant dissociative effects were evident using the Side Effects Rating Scale for Dissociative Anaesthetics. Conclusion: Intranasal ketamine may offer a safe, nonopioid, well-tolerated, needle-free analgesic with efficacy in moderate-to-severe acute pain.
机译:背景:氯胺酮的麻醉剂量为镇痛药。鼻内给药为全身给药提供了一种非侵入性途径。我们在磨牙拔除模型中评估了鼻内氯胺酮在治疗中度至重度急性术后疼痛中的安全性和镇痛效果。方法:在一项随机,双盲,单剂量,平行研究中,对40例接受2-4次第三磨牙治疗的患者进行了鼻内氯胺酮(10 mg,30 mg和50 mg)和安慰剂的评估。在给药后3小时内评估镇痛效果。通过不良事件报告,生命体征,脉搏血氧饱和度,鼻腔评估和标准的分离性副作用调查表评估安全性。结果:鼻内注射的氯胺酮耐受性良好。在3小时内,以最高测试剂量50 mg观察到了优于安慰剂的统计学上显着的镇痛效果。据报道,镇痛迅速发作(<10分钟),在50毫克剂量的15分钟内达到了有效的止痛效果。大多数不良事件是轻度/弱和短暂的。在生命体征,脉搏血氧饱和度和鼻腔检查中未观察到不良影响。在测试剂量下,使用《离体麻醉药副作用分级量表》没有明显的离解作用。结论:鼻内氯胺酮可提供一种安全,非阿片类药物,耐受性良好,无针镇痛药,对中至重度急性疼痛有效。

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