Effect of Premedicant Oral Paracetamol on Gastric Volume and pH

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: King's College Hospital NHS Trust
• Collaborator: Barts & The London NHS Trust
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

• Elective surgery

• Requiring tracheal intubation for general anaesthesia

• Parent/guardian able to speak and understand written English

Exclusion Criteria:

• Known or suspected gastro-intestinal disease including varices

• Previous surgery which may alter gastric emptying or the anatomy of the oesophagus or stomach

• Anticipated difficult airway

• Concomitant administration of any other medication orally prior to anaesthesia, but excluding buccal sedative pre-medication eg midazolam

• Bleeding disorders

• Patients taking antacids or pro-kinetic drugs, or requiring them pre-operatively

• Allergy to paracetamol

• Patient weight greater than 25 kg

• Parental or patient refusal