Excessive crying in children with cerebral palsy and communication deficits - a fixed-sequence, crossover clinical trial

Aim: To study epidemiology, response to drug therapy, and a drug taper after 250 days of treatment of excessive crying in children with cerebral palsy with communication deficits (ECCCPCD). Methods: : This was a fixed-sequence crossover study of 131 consecutive subjects 7.5 hours crying duration/day for 30 straight days. Outcome measures were epidemiological data, measurement of means of total and unexplained ECCCPCD durations (TECCCPCCD and UECCCPCD) while on the placebo (M1), while on treatment (M2-M5), and the effect of a drug taper (M4). Results: 74% were <2 years; 65% were males. Paired t-tests between TECCCPCCD of M1-M2 yielded a mean difference of -3.67 (95% CI -3.80 to -3.53), p<0.001; between UECCCPCCD of M1-M2,-3.04 (95% CI -3.16 to -2.93), p<0.001. Wilcoxon tests between TECCCPCCD of M1-M5 yielded medians of 9.98 (95% CI 9.73 to 10.16) and 2.67 (95% CI 2.53 to 2.82), p<0.001. Wilcoxon tests between UECCCPCCD of M1-M5 yielded medians of 8.22 (95% CI 8.02 to 8.39) and 2.16 (95% CI 2.04 to 2.28), p<0.001. The dosage could be tapered in 51.15% of participants. Conclusions: Treatment of spasticity, dystonia, visceral, and neuropathic pain reduced crying. The drug requirement was less after 250 days of treatment.