Complex regional pain syndrome (CRPS) is a chronic pain disorder that typically follows trauma or surgery. Suspected CRPS reported after vaccination with human papillomavirus (HPV) vaccines led to temporary suspension of proactive recommendation of HPV vaccination in Japan. We investigated the potential CRPS signal in relation to HPV-16/18-adjuvanted vaccine (Cervarix®) by database review of CRPS cases with independent expert confirmation; a disproportionality analysis and analyses of temporality; an observed versus expected analysis using published background incidence rates; systematic reviews of aggregate safety data, and a literature review.The analysis included 17 case reports of CRPS: 10 from Japan (0.14/100,000 doses distributed) and seven from the United Kingdom (0.08/100,000). Five cases were considered by independent experts to be confirmed CRPS. Quantitative analyses did not suggest an association between CRPS and HPV-16/18-adjuvanted vaccine. Observed CRPS incidence after HPV-16/18 vaccination was statistically significantly below expected rates. Systematic database reviews using search terms varying in specificity and sensitivity did not identify new cases. No CRPS was reported during clinical development and no unexpected results found in the literature.There is not sufficient evidence to suggest an increased risk of developing CRPS following vaccination with HPV-16/18-adjuvanted vaccine. Post-licensure safety surveillance confirms the acceptable benefit-risk of HPV-16/18 vaccination.
Preoxygenation is a simple technique to expand the time under planned apnea till the patient is endangered by hypoxia. In this study, we analysed how preoxygenation is used by anaesthesiologists in clinical routine and how this method is tolerated by the patients. One hundred and twenty-one anaesthesiologists of 4 hospitals were interviewed anonymously about training level, rank, indication for preoxygenation and techniques of preoxygenation, as well as their estimation of the patients' discomfort during preoxygenation. Data on 100 patients about oxygen-mask-tolerance were acquired by an anonymous questionnaire from a standard quality control inquiry. We received back 76 of the 121 questionnaires of anaesthesiologists (63 %). Fifty-nine percent of the anaesthesiologists (45/76) preoxygenated in clinical routine. With increasing training time and higher ranks, less anaesthesiologists preoxygenated routinely: junior residents: 80 %; senior residents: 68 %; consultants: 60 %; assistant medical directors: 48 %.80 % of the anaesthesiologists (61/76) used imperfect techniques for preoxygenation (e. g. oxygen-flow < 8 l/min). At the time of preoperative evaluation, the patients estimated the discomfort during preoxygenation on a continuous scale (1 to 10) as 2 (median; 1 - 7: 95 % confidence interval). Postoperatively, the patients mentioned no discomfort: 1 (1 - 1). The anaesthesiologists overestimated their patients' discomfort significantly with 5 (3 - 7) (p < 0.001).In conclusion, preoxygenation, a simple safety procedure, is not routinely used by many anaesthesiologists and imperfect methods are often employed. A possible reason for the anaesthesiologists' reluctance to preoxygenate is an overestimation of the patients' discomfort, though the patients tolerate preoxygenation very well.
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