Do clowns attenuate pain and anxiety undergoing botulinum toxin injections in children?

[OBJECTIVE] Botulinum toxin injection (BTI) is the primary treatment for spasticity in children. Anxiety and pain are important concerns to address to attenuate the discomfort of BTI. The aim of this study was to compare the effectiveness of medical clowns and usual distractions, both added to nitrous oxide (NO) and analgesic cream, on pain and anxiety during BTI sessions in children.

[METHODS] The primary outcome was pain evaluated by the Face, Legs, Activity, Cry, Consolability (FLACC) scale. Secondary criteria were pain rated on a Visual Analog Scale (VAS) by the child and parent, anxiety rated on a VAS before and during BTIs by the child and parent(s), rating of the success of the sessions on a 4-point Likert scale by the physician and parent(s), and rating of the benefits of the distraction by the parent(s). Non-parametric tests were used for between-group comparisons.

[RESULTS] Baseline group characteristics of the clown and control groups did not differ. During 88 BTI sessions (40 with clown distraction and 48 with control distraction) in 59 children (35 boys; 52 with cerebral palsy, 12 with moderate to severe cognitive disorders), median maximal FLACC score was 2.5 (interquartile range [IQR]: 1-4) in the clown group and 3 (IQR: 1-4.3) in the control group. VAS self-reported pain score was 2.5 (IQR: 0-5) and 3 (IQR: 1-6.3) in the clown and control groups (P=0.56), and VAS proxy-reported pain score was 2.5 (IQR: 0.3-3.4) and 3 (IQR: 1-4.5) (P=0.25). After BTI sessions, the 2 groups did not differ in VAS self- and proxy-reported anxiety (P=0.83 and P=0.81). Physician and parent ratings of the success of sessions were similar between the groups (P=0.89 and P=0.11). Parent ratings of the perceived benefits of distraction were higher in the clown than control group (P=0.004).

[CONCLUSIONS] Although clown distraction was particularly appreciated by parents, it did not significantly reduce pain or anxiety in children as compared with usual distraction.

[TRIAL REGISTRATION] ClinicalTrials.gov ID: NCT03149263.