Effectiveness of sedation using nitrous oxide compared with enteral midazolam for botulinum toxin A injections in children

This randomized, double-blind, placebo-controlled study compared the efficacy of inhaled nitrous oxide (N2O) with enteral midazolam for sedation of children with cerebral palsy (CP) undergoing botulinum toxin A (BoNT-A) injections. Fifty children (29 males, 21 females; mean age 8y 2mo [SD 4y 5mo]; range 1-16y) were randomized to sedation with N2O (n=25) or midazolam (n=25). Groups were similar in type of CP (diplegia, 11; triplegia, three; quadriplegia, 16; hemiplegia, 16; other, three) and Gross Motor Function Classification System level (Level I, 4; II, 24; III, 4; IV, 13; V, 5). Both groups were equally sedated at time of injection (p=0.661), but those in the midazolam group were more sedated at time of discharge (p<0.001). N2O was more effective in reducing pain compared with midazolam as measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale (p=0.010), parental estimate of pain (p=0.009), and nursing estimate of pain (p=0.007). Parents in the N2O group rated it better than prior sedation with midazolam for BoNT-A injections (p=0.031). Physicians and nurses reported no difference in ease of procedure between the groups. One child in the midazolam group and eight in the N2O group had adverse effects, all of which resolved promptly. N2O appears to be an effective means of sedation for children undergoing outpatient BoNT-A injections.