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Background and Aims

Background and aims: Superantigen toxins synthesized by Staphylococcus aureus and Streptococcus pyogenes are responsible for toxic shock syndromes (TSS), which lethality can reach 28% in children. In vitro, high concentration of Intravenous Immunoglobulins (IVIG) neutralize their toxicity. No randomized controlled trial (RCT) on IVIG efficacy in TSS has been conducted in children.

Before launching such a prospective RCT, a pilot study is required, with objective to assess the feasibility including inclusion rate, protocol deviations, and missing data.

Methods

We performed a multicenter, double-blind, pilot RCT. We planned to recruit, over 24 months, 20 patients with suspicion of TSS and criteria of septic shock, aged from 1 month to 18 years, admitted within 9 French paediatric intensive care units. The experimental group received IVIG10% (2g/kg) and the control group Albumin4% (0,8g/kg). There were 12 months of follow-up.

Results

79 children with TSS were assessed for eligibility, including 49 eligible, among which 30 (61%) were recruited within 38 months. Median Pelod 2 score at inclusion was 6 (0-11). 29 patients received allocated treatment (97%) and 9 patients (30%) had at least one protocol deviation. There were no missing data on key data for primary endpoint. 9 patients (30%) presented serious adverse events (no death)

Conclusions

This first RCT in paediatric TSS shows the feasibility of such a trial with only a few adjustments. As recommended by the Data Safety Monitoring Board, an international multicentre efficacy study is required to perform this trial.

Background and Aims

Many critically ill children receive polypharmacy in pediatric intensive care units(PICUs). As the metabolism of drugs in critically ill children is altered, they have a higher risk for potential drug-drug interactions (pDDI). We aimed to investigate the common drug profile in Turkish PICUs, and risks for pDDI.

Methods

This was a cross-sectional point prevalence study with Institutional Review Board approval.Fifty PICUs participated in the survey, submitted data online. All medications were analyzed by two clinical pharmacists for possible interactions.

Results

A total of 526 patients(60% male; median age 17.5 months) were captured. Most common admission diagnoses were pneumonia(40%) and respiratory failure(21%). Majority had comorbidities(79%), mainly of neurologic system, and 70% received invasive mechanical ventilation. Median number of medications were 8 (IQR 7, max 27)

Thirty-eight(7.2%) patients had risk for category X pDDI, whereas 259(49.3%) had risk for one or more class category D pDDI. Drugs frequently involved with pDDI were central nervous system medications(70%), antibiotics(13%) gastrointestinal system(5%) medications(p<0.001). pDDI risk increased from 35.8% to 64.2% in patients who use antiepileptic drugs(p <0.001, odds ratio 3.05).

Conclusions

Critically ill children exposed to polypharmacy are at high risk for pDDI, especially in patients who previously used antiepileptic drugs. Although this risk does not always translate to clinically manifested interaction. Having automatic warning systems about these drug interactions in hospital drug operating systems will increase the awareness of drug-drug interactions among clinicians. Implementation of real time pDDI notification and screening for adverse events could help to define the real risk, and contribute to patient safety.

Background and Aims

Longterm intravenous sedation in critically ill children can be challenging, due to its not desirable side effects. Our aims are to describe our experience with inhaled sevoflurane (InS) and its effects in critically ill children. We also wondered if patients admitted due to respiratory failure needed more iv sedation and if children under 4 years had a higher risk of complications.

Methods

Single-center retrospective study in a 12-bed PICU in a terciary-care academic medical center. All patients treated with InS using AnaConDa ® device between January 2014 and december 2020.

Results

37 children received InS. 56.8% were male. Median age: 7 months (IQR 4.5-17mo). Diagnoses at admission: 54.1% respiratory disease, 18.9% postsurgery requiring mechanical ventilation, 10.8% postoperative heart surgery and 5.4% post cardiac arrest. Most frequent indication for using: rotation of sedative drugs (91.9%). Median duration of treatment: 72 h (IQR 37.5-96.5). Before InS was started, 83.8% were receiving 3 or more drugs. Benzodiazepines were the drugs more frequently used (75.7%).

Monitoring with Bispectral Index Score (BIS) and COMFORT Scale were used in 25.8 and 74.9%, respectively. We always monitored sevoflurane exhaled concentration when in use.

The most frequent side effects were distonia (26%) seizure (8%) and hypotension (5.4%).

Respiratory patients didn´t need more iv drugs (p 0.4) and side effects were not more frequent in younger patients (p 1)

Conclusions

InS is effective in patients difficult to sedate. Side effects were transient and responded to drug treatment Either respiratory patients required more iv drugs nor side effects were more frequent in younger patients