drugset / Trial / NCT04625608

Effect of Premedicant Oral Paracetamol on Gastric Volume and pH

NCT04625608 ↗

RandomizedParallel-groupSingle-blindTreatment

Summary

Patients are asked to fast before general anaesthesia to reduce the risk that any gastric contents could be regurgitated and aspirated into the lungs once anaesthetised. If aspiration does occur, the volume and acidity of the fluid aspirated are thought to determine the extent of any harm caused. Recent guidelines have reduced the required fasting time for children for clear fluids from 2 hours to 1 hour before induction of anaesthesia, as it is understood that this does not adversely affect the gastric residual volume or increase its acidity. Paracetamol is commonly used to relieve pain during and after surgery. Paracetamol syrup preparations used in children are viscous and not classified as clear fluid. This study seeks to establish whether there is non-inferiority in gastric residual volume (GRV) and pH in children receiving oral paracetamol one hour before induction of anaesthesia and those who do not, when both groups have received a set volume of diluted orange cordial to drink. It is anticipated that if shown to have little or no impact on GRV and pH, oral paracetamol syrup can be given to children before surgery. This will omit the need for IV paracetamol to be given in theatre, potentially reducing cost and the risk of drug errors.

Timeline

Start
2020-10-06
Primary completion
2021-08
Completion
2021-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 15 mg/kg Oral

Indications

No indication recorded.