Publication bias in pediatric emergence delirium: a cross-sectional analysis of ClinicalTrials.gov and ClinicalTrialsRegister.eu

Abstract

ObjectivesEmergence delirium (ED) is a frequent and potentially serious complication of general anaesthesia in children. Although there are various treatment strategies, no general management recommendations can be made. Selective reporting of study results may impair clinical decision-making. We, therefore, analysed whether the results of completed registered clinical studies in patients with paediatric ED are publicly available or remain unpublished.DesignCross-sectional analysis.SettingClinicalTrials.gov and ClinicalTrialsRegister.eu.Participants and outcome measuresWe determined the proportion of published and unpublished studies registered at ClinicalTrials.gov and ClinicalTrialsRegister.eu that were marked as completed by 1st September 2018. The major trial and literature databases were used to search for publications. In addition, the study investigators were contacted directly. For published trials, time to publication was calculated as the difference in months between study completion date and publication date.ResultsOf the 44 registered studies on paediatric ED, only 24 (54%) were published by September 2019. Published trials contained data from n=2556 patients, whereas n=1644 patients were enrolled in unpublished trials. Median time to publication was 19 months. Studies completed in recent years were published faster, but still only 9 of 24 trials were published within 12 months of completion.ConclusionThere is a distinct publication gap in clinical research in paediatric ED that may have an impact on meta-analyses and clinical practice.

Incidence of Emergence Delirium in the Pediatric PACU: Prospective Observational Trial

“…The incidence of ED in our patient population was 18.1–89.0% depending on the scoring system used, in accordance with previous studies [ 6 ].…”

“…The incidence of ED when using a PAED score with a cutoff ≥10 points vs. cutoff >12 showed a statistically significant difference. This corresponds with the false positive findings by Meyburg et al, where the optimal sensitivity and specificity were achieved with the cutoff >12 points, while the cutoff ≥10 points was considered to be set too low [ 6 ]. The incidence of ED by the Watcha, RASS scale and the PAED score with a cutoff >12 points were comparable; moreover, the cumulative duration of ED was the same in 86.3% ( n = 139) of these patients, from which we can deduce a good ability of these scoring systems to assess ED over time.…”

“…The described incidence of ED is unfortunately not clear and is burdened with a significant publication bias, as it depends on the definition of ED and the screening tool used. Various resources state that the incidence of ED is between 25% and 80%, with a higher prevalence among young children under 6 years of age [ 5 , 6 ]; however, ED can occur in even younger children and infants [ 7 , 8 ].…”

“…The authors consider the use of a threshold above ≥10 points to be specific to the diagnosis of ED. Previous studies have shown that a threshold of ≥10 points shows falsely high positive results; therefore, a threshold of >12 points might be more beneficial [ 6 ]. Moreover, the score is quite complicated and is considered lengthy by many anesthetists; it is also not entirely clear when after the end of general anesthesia the scoring should be initiated.…”

Effect of Intranasal versus Intravenous Fentanyl on the Emergence Agitation after Sevoflurane Anesthesia in Children Undergoing Bilateral Myringotomy: A Prospective Randomized Controlled Double-Blinded Study

“…Fentanyl at a dose of (2.5 g g/kg i.v) decreases the incidence of emergence agitation in patients who have undergone adenoidectomy with or without BMT surgery using sevoflurane and/or desflurane [6] .…”