Design and reporting characteristics of clinical trials investigating sedation practices in the paediatric intensive care unit: a scoping review by SCEPTER (Sedation Consortium on Endpoints and Procedures for Treatment, Education and Research)

Abstract

Objectives: To conduct a scoping review of sedation clinical trials in the paediatric intensive care setting and summarise key methodological elements.

Design: Scoping review.

Data sources: PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature and grey references including ClinicalTrials.gov from database inception to 3 August 2021.

Study selection: All human trials in the English language related to sedation in paediatric critically ill patients were included. After title and abstract screening, full-text review was performed. 29 trials were eligible for final analysis.

Data extraction: A coding manual was developed and pretested. Trial characteristics were double extracted.

Results: The majority of trials were single centre (22/29, 75.9%), parallel group superiority (17/29, 58.6%), double-blinded (18/29, 62.1%) and conducted in an academic setting (29/29, 100.0%). Trial enrolment (≥90% planned sample size) was achieved in 65.5% of trials (19/29), and retention (≥90% enrolled subjects) in 72.4% of trials (21/29). Protocol violations were reported in nine trials (31.0%). The most commonly studied cohorts were mechanically ventilated patients (28/29, 96.6%) and postsurgical patients (11/29, 37.9%) with inclusion criteria for age ranging from 0±0.5 to 15.0±7.3 years (median±IQR). The median age of enrolled patients was 1.7 years (IQR=4.4 years). Patients excluded from trials were those with neurological impairment (21/29, 72.4%), complex disease (20/29, 69.0%) or receipt of neuromuscular blockade (10/29, 34.5%). Trials evaluated drugs/protocols for sedation management (20/29, 69.0%), weaning (3/29, 10.3%), daily interruption (3/29, 10.3%) or protocolisation (3/29, 10.3%). Primary outcome measures were heterogeneous, as were assessment instruments and follow-up durations.

Conclusions: There is substantial heterogeneity in methodological approach in clinical trials evaluating sedation in critically ill paediatric patients. These results provide a basis for the design of future clinical trials to improve the quality of trial data and aid in the development of sedation-related clinical guidelines.

Keywords: clinical trials; paediatric intensive & critical care; protocols & guidelines; statistics & research methods.