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Effectiveness of a single dose of oral vs rectal paracetamol in reducing fever in children aged between 2 to 6 years ? A Randomized Controlled Trial
Nalaka Sanjeewa Imbulana, Lakkumar Fernando
Background: Rectal route of paracetamol is preferred to the commonly used oral route in some instances. Yet there is no previous documented study comparing the two routes in the local setting.
Methods: Single-centre, balanced randomized [1:1], two arms, parallel-group clinical trial was conducted in single Paediatric ward at the Gampaha District General Hospital, Sri Lanka. Children aged between 2-6 years with documented axillary temperature > 100° F were enrolled. Children were randomly divided into two arms with 135 participants in each arm. The first arm received single doses of 15 mg/kg oral paracetamol and second group received single doses of 30 mg/kg rectal paracetamol. A data extraction sheet was to record temperature at baseline and at 15 minutes, 30 minutes,1 hour, 1 and1/2 hours, 2 hours, 2 and ½ hours and 3 hours after administration of the drug. The rate of temperature (time taken fever reduction by at least 1 F) reduction was calculated in 270 sample. In addition, the potential adverse events of the both groups were recorded.
Results: In the oral group, mean temperature reductions at 15 minutes, 30 minutes, 1 hour, 1 and1/2 hours, 2 hours, 2 and ½ hours and 3 hours after administration of the drug were 0.11, 0.44, 1.06, 1.68, 2.10, 3.18 and 2.75 0F respectively. The respective temperature reductions in rectal group were 0.26, 0.67, 1.31, 3.52, 2.81, 3.33 and 4.45 0F.When compared the means of both groups there was statistically significant difference between two groups in all the time periods (P<0.05) except at 1 hour after administration of paracetamol (P = 0.06). There was no statistical significant difference in side effects when comparing two arms as well.
Conclusion: A single dose of 30 mg/kg rectal paracetamol is more effective than single dose of 15 mg/kg oral paracetamol in reducing fever. There is no difference in relation to the safety of the two routes. Trial registration: SLCTR, SLCTR/2017/025. Registered 17 August 2017-Retrospectively registered, https://slctr.lk/ SLCTR/2017/025