Intravenous Acetaminophen vs Intravenous Diclofenac Sodium in Management of Skeletal Vaso-occlusive Crisis Among Children with Homozygous Sickle Cell Disease: A Randomized Controlled Trial.

OBJECTIVE

To compare the efficacy of intravenous acetaminophen and intravenous diclofenac sodium in the management of skeletal vaso-occlusive crisis among children with sickle cell disease.

DESIGN

Single blind randomized controlled trial.

SETTING

Tertiary care hospital.

PARTICIPANTS

104 children with sickle cell disease and skeletal vaso-occlusive crisis.

INTERVENTION: Intravenous acetaminophen at 10mg/kg/dose 8 hourly and intravenous diclofenac sodium at 1mg/kg/dose 8 hourly in 1:1 ratio.

MAIN OUTCOME MEASURES: Reduction in pain score (50%), number of doses needed to relieve pain after 24 hours of drug administration and decrease in pain score at 1 hour.

RESULTS

A 50% reduction in pain score was seen in 35 (77.3%) and 10 (21.7%) children among acetaminophen and diclofenac sodium groups respectively (RR, 95% CI 3.6; 2.02-6.33, P< 0.001). The mean (SD) fall in pain score at 1 hour was significantly higher among intervention arm as compared to control arm [1.51 (0.5) and 1.06 (0.5); P<0.001]. Eight (17.4%) patients developed local phlebitis at the site of infusion among diclofenac group.

CONCLUSIONS

Intravenous acetaminophen is a better alternative to intravenous diclofenac in children with skeletal vaso-occlusive crisis.