Prednisolondrank beter te verdragen en effectiever dan prednisolonpoeder bij de behandeling van astma-exacerbaties bij kinderen

To compare the tolerability and clinical efficacy of prednisolone oral solution and prednisolone powder for the treatment of acute severe asthma in children.

Design

Randomized controlled clinical trial.

Method

In the period August 1998 to November 1999, at the outpatients' clinic and paediatric ward of the Isala teaching hospital (Zwolle, the Netherlands), 78 children (48 male) aged 3 months to 7 years, with acute severe asthma were treated with prednisolone 1 mg/kg twice daily. This was given as either an oral solution or a powder for 5 days, with bronchodilators per inhalation if necessary. Withdrawal from the study due to repeated vomiting of the study medication was registered. In a diary the parents recorded the severity of the dyspnoea and the taste of the prednisolone formulation using a visual analogue scale (VAS). At the start of the study the child's clinical condition was determined; after 6-8 days an assessment was carried out by a paediatric pulmonologist who did not know in which form the prednisolone had been administered.

Results

Nine patients (23) withdrew from the powder group because of repeated vomiting on the first study day, compared to 0 in the oral solution group (p = 0.001). Taste VAS scores were significantly better for prednisolone oral solution than for powder (95 CI for difference 2.0-5.1; p < 0.001). Differences in dyspnoea VAS scores between the study groups were not significant. The majority of patients (43/64; 67) improved promptly during prednisolone therapy, and dyspnoea VAS scores returned to zero after 3-7 days. Eleven patients (17) showed temporary worsening of dyspnoea during prednisolone therapy, and 10 patients (16) showed a prolonged clinical course with slow decrease of dyspnoea. At the follow-up after 6-8 days, 18/29 patients (62) from the powder group had recovered completely, compared to 29/35 patients (83) from the oral solution group (p = 0.06).

Conclusion

In children with acute severe asthma, prednisolone oral solution was better tolerated than and at least as effective as prednisolone powder. Irrespective of the drug formulation, approximately one third of the children with acute severe asthma responded slowly or poorly to prednisolone therapy.