Abstract
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.
Conclusion
Intravenous acetaminophen is a better alternative to intravenous diclofenac in children with skeletal vaso-occlusive crisis.
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Veer Surendra Sai Institutional Research and Ethics Committee (VIREC); No: 2015/P-I-RP/128, dated 15 November, 2015.
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PCP: conceptualization and critical inputs to manuscript writing; NRM: data collection and writing the manuscript; NRM, CP and BKN: data collection, analysis and critical inputs to manuscript writing; SKP: supervision of the work and revision of manuscript.
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Panda, P.C., Mishra, N.R., Patra, C.S. et al. Intravenous Acetaminophen vs Intravenous Diclofenac Sodium in Management of Skeletal Vaso-occlusive Crisis Among Children with Homozygous Sickle Cell Disease: A Randomized Controlled Trial. Indian Pediatr 58, 229–232 (2021). https://doi.org/10.1007/s13312-021-2160-3
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DOI: https://doi.org/10.1007/s13312-021-2160-3