A prospective study of adverse drug reactions to antiepileptic drugs in children.

OBJECTIVES: To prospectively determine the nature and rate of adverse drug reactions (ADRs) in children on antiepileptic drugs (AEDs) and to prospectively evaluate the effect of AEDs on behaviour. SETTING: A single centre prospective observational study. PARTICIPANTS: Children (<18 years old) receiving one or more AEDs for epilepsy, at each clinically determined follow-up visit. PRIMARY AND SECONDARY OUTCOMES: Primary outcome was adverse reactions of AEDs. Behavioural and cognitive functions were secondary outcomes. RESULTS: 180 children were recruited. Sodium valproate and carbamazepine were the most frequently used AEDs. A total of 114 ADRs were recorded in 56 of these children (31%). 135 children (75%) were on monotherapy. 27 of the 45 children (60%) on polytherapy had ADRs; while 29 (21%) of those on monotherapy had ADRs. The risk of ADRs was significantly lower in patients receiving monotherapy than polytherapy (RR: 0.61, 95% CI 0.47 to 0.79, p<0.0001). Behavioural problems and somnolence were the most common ADRs. 23 children had to discontinue their AED due to an ADR. CONCLUSIONS: Behavioural problems and somnolence were the most common ADRs. Polytherapy significantly increases the likelihood of ADRs in children. TRAIL REGISTRATION NUMBER: EudraCT (2007-000565-37).

Randomized controlled trial of the intraligamental use of a local anaesthetic (lignocaine 2%) versus controls in paediatric tooth extraction.

BACKGROUND: Children still experience pain upon waking following dental extraction under general anaesthesia. Local anaesthetic has been shown to reduce this pain, but needs to be administered via a method that causes minimum injury or distress to the child. AIM: This study aims to evaluate the use of intraligamental injection of local anaesthetic, under general anaesthesia prior to the extraction of the tooth, for postoperative pain control in children aged 2-5 years. DESIGN: A randomized, single-blind, controlled trial of intraligamental lignocaine (2% lignocaine solution with adrenaline (epinephrine) 1 : 80 000) for primary teeth extraction under general anaesthesia was performed. Pain was scored by the investigators at 5-, 15-, 30-, and 60-min time points in the first hour using the Toddler-Preschooler Postoperative Pain Scale. RESULTS: Eighty-six children were recruited in the study: 42 randomized in the lignocaine treatment group and 44 in the control group. There was no significant difference (P = 0.42, Mann-Whitney U-test) in the cumulative four time point median pain score over the first hour. In the lignocaine treatment group, this was 3 (interquantile range (IQR) 0-7.5) and in the control group this was 3 (IQR: 0-10). At the 5-min time point after the child returned from recovery, the pain score in the lignocaine group (0 IQR 0-1) was statistically lower than that in the control group (0 IQR 0-5) (P = 0.023). There was no difference in the 15-, 30-, or 60-min time points. CONCLUSIONS: Intraligamental lignocaine used for dental extraction under general anaesthesia in young children initially causes less pain after recovery, but this difference is not sustained over the first hour after dental extraction.