Comparison of the use of the Valsalva maneuver and the eutectic mixture of local anesthetics (EMLA®) to relieve venipuncture pain: a randomized controlled trial

Süren, Mustafa; Kaya, Ziya; Özkan, Fatih; Erkorkmaz, Ünal; Arıcı, Semih; Karaman, Serkan

doi:10.1007/s00540-012-1540-1

Cited by 25 publications

(38 citation statements)

References 26 publications

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“…Another factor that could theoretically contribute to placebo (and potentially active drug) response may be related to neurochemical effects of CO 2 delivery and/or removal of NO at the trigeminal nerve endings within the nasal cavity. Since AVP‐825 redirects exhaled air deep into the nasal cavity, it has an added advantage of broadly exposing deep intranasal structures innervated by the first branch of the trigeminal nerve to positive pressure and high airflow of exhaled air . The increased Bi‐Directional airflow (in one nostril, out the other) may locally replace the elevated levels of NO found in this region with exhaled air containing 5‐6% CO 2 .…”

Section: Discussionmentioning

confidence: 99%

A Randomized, Double‐Blind, Placebo‐Controlled Study of Breath Powered Nasal Delivery of Sumatriptan Powder (AVP‐825) in the Treatment of Acute Migraine (The TARGET Study)

et al. 2014

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ObjectiveTo evaluate the efficacy and safety of AVP-825, a drug–device combination of low-dose sumatriptan powder (22 mg loaded dose) delivered intranasally through a targeted Breath Powered device vs an identical device containing lactose powder (placebo device) in the treatment of migraine headache.BackgroundEarly treatment of migraine headaches is associated with improved outcome, but medication absorption after oral delivery may be delayed in migraineurs because of reduced gastric motility. Sumatriptan powder administered with an innovative, closed-palate, Bi-Directional, Breath Powered intranasal delivery mechanism is efficiently absorbed across the nasal mucosa and produces fast absorption into the circulation. Results from a previously conducted placebo-controlled study of AVP-825 showed a high degree of headache relief with an early onset of action (eg, 74% AVP-825 vs 38% placebo device at 1 hour, P < .01).MethodsIn this double-blind, placebo-controlled, parallel-group study in adults with a history of migraine with or without aura, participants were randomized via computer-generated lists to AVP-825 or placebo device to treat a single migraine headache of moderate or severe intensity. The primary endpoint was headache relief (defined as reduction of headache pain intensity from severe or moderate migraine headache to mild or none) at 2 hours post-dose.ResultsTwo hundred and thirty patients (116 AVP-825 and 114 placebo device) were randomized, of whom 223 (112 and 111, respectively) experienced a qualifying migraine headache (their next migraine headache that reached moderate or severe intensity). A significantly greater proportion of AVP-825 patients reported headache relief at 2 hours post-dose compared with those using the placebo device (68% vs 45%, P = .002, odds ratio 2.53, 95% confidence interval [1.45, 4.42]). Between-group differences in headache relief were evident as early as 15 minutes, reached statistical significance at 30 minutes post-dose (42% vs 27%, P = .03), and were sustained at 24 hours (44% vs 24%, P = .002) and 48 hours (34% vs 20%, P = .01). Thirty-four percent of patients treated with AVP-825 were pain-free at 2 hours compared with 17% using the placebo device (P = .008). More AVP-825 patients reported meaningful pain relief (patient interpretation) of migraine within 2 hours of treatment vs placebo device (70% vs 45%, P < .001), and fewer required rescue medication (37% vs 52%, P = .02). Total migraine freedom (patients with no headache, nausea, phonophobia, photophobia, or vomiting) reached significance following treatment with AVP-825 at 1 hour (19% vs 9%; P = .04). There were no serious adverse events (AEs), and no systemic AEs occurred in more than one patient. Chest pain or pressure was not reported, and only one patient taking AVP-825 reported mild paresthesia. No other triptan sensations were reported.ConclusionsTargeted delivery of a low-dose of sumatriptan powder via a novel, closed-palate, Breath Powered, intranasal device (AVP-825) provided fast relief of moderate or s...

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Section: Discussionmentioning

confidence: 99%

A Randomized, Double‐Blind, Placebo‐Controlled Study of Breath Powered Nasal Delivery of Sumatriptan Powder (AVP‐825) in the Treatment of Acute Migraine (The TARGET Study)

et al. 2014

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“…The decreased hypersensitivity was reversed by IV atropine, suggesting involvement of muscarinic cholinergic receptors . Suren et al found that the Valsalva maneuver was comparable to local anesthetic gel in reducing venipuncture pain …”

Section: Recent Trials and Research On Vnsmentioning

confidence: 99%

Vagus Nerve and Vagus Nerve Stimulation, a Comprehensive Review: Part III

2015

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Vagus nerve stimulation (VNS) is currently undergoing multiple trials to explore its potential for various clinical disorders. To date, VNS has been approved for the treatment of refractory epilepsy and depression. It exerts antiepileptic or antiepileptogenic effect possibly through neuromodulation of certain monoamine pathways. Beyond epilepsy, VNS is also under investigation for the treatment of inflammation, asthma, and pain. VNS influences the production of inflammatory cytokines to dampen the inflammatory response. It triggers the systemic release of catecholamines that alleviates the asthma attack. VNS induces antinociception by modulating multiple pain-associated structures in the brain and spinal cord affecting peripheral/central nociception, opioid response, inflammation process, autonomic activity, and pain-related behavior. Progression in VNS clinical efficacy over time suggests an underlying disease-modifying neuromodulation, which is an emerging field in neurology. With multiple potential clinical applications, further development of VNS is encouraging.

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“…In the present Breath Powered device, it is postulated that the oscillating capsule and airflow may significantly enhance exchange of air in upper narrow parts of the nose, as in part observed in response to humming and pulsating nebulizers . In addition, there are reasons to hypothesize that potential positive effects mediated by the positive air pressure, rapid vibrations produced by the rattling capsule, and the removal of NO may all play a role in alleviating migraine headache . One or more of these, or other, device‐related mechanisms may contribute to the high response rate in the placebo groups in the trials with Breath Powered powder delivery in migraine patients.…”

Section: Optinose Breath Powered Deliverymentioning

confidence: 99%

Breath Powered Nasal Delivery: A New Route to Rapid Headache Relief

2013

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The nose offers an attractive noninvasive alternative for drug delivery. Nasal anatomy, with a large mucosal surface area and high vascularity, allows for rapid systemic absorption and other potential benefits. However, the complex nasal geometry, including the narrow anterior valve, poses a serious challenge to efficient drug delivery. This barrier, plus the inherent limitations of traditional nasal delivery mechanisms, has precluded achievement of the full potential of nasal delivery. Breath Powered bi-directional delivery, a simple but novel nasal delivery mechanism, overcomes these barriers. This innovative mechanism has now been applied to the delivery of sumatriptan. Multiple studies of drug deposition, including comparisons of traditional nasal sprays to Breath Powered delivery, demonstrate significantly improved deposition to superior and posterior intranasal target sites beyond the nasal valve. Pharmacokinetic studies in both healthy subjects and migraineurs suggest that improved deposition of sumatriptan translates into improved absorption and pharmacokinetics. Importantly, the absorption profile is shifted toward a more pronounced early peak, representing nasal absorption, with a reduced late peak, representing predominantly gastrointestinal (GI) absorption. The flattening and “spreading out” of the GI peak appears more pronounced in migraine sufferers than healthy volunteers, likely reflecting impaired GI absorption described in migraineurs. In replicated clinical trials, Breath Powered delivery of low-dose sumatriptan was well accepted and well tolerated by patients, and onset of pain relief was faster than generally reported in previous trials with noninjectable triptans. Interestingly, Breath Powered delivery also allows for the potential of headache-targeted medications to be better delivered to the trigeminal nerve and the sphenopalatine ganglion, potentially improving treatment of various types of headache. In brief, Breath Powered bi-directional intranasal delivery offers a new and more efficient mechanism for nasal drug delivery, providing an attractive option for improved treatment of headaches by enabling or enhancing the benefits of current and future headache therapies.

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Comparison of the use of the Valsalva maneuver and the eutectic mixture of local anesthetics (EMLA®) to relieve venipuncture pain: a randomized controlled trial

Abstract: The Valsalva maneuver yields similar results to the EMLA(®) in terms of pain reduction during venipuncture.

Cited by 25 publications

References 26 publications

A Randomized, Double‐Blind, Placebo‐Controlled Study of Breath Powered Nasal Delivery of Sumatriptan Powder (AVP‐825) in the Treatment of Acute Migraine (The TARGET Study)

A Randomized, Double‐Blind, Placebo‐Controlled Study of Breath Powered Nasal Delivery of Sumatriptan Powder (AVP‐825) in the Treatment of Acute Migraine (The TARGET Study)

Vagus Nerve and Vagus Nerve Stimulation, a Comprehensive Review: Part III

Breath Powered Nasal Delivery: A New Route to Rapid Headache Relief

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