Does oral diclofenac together with oral paracetamol affect gastric volumes and pH in children?

ISRCTN	ISRCTN40177280
DOI	https://doi.org/10.1186/ISRCTN40177280
Protocol serial number	N0205128931
Sponsor	Department of Health
Funder	Barts and The London NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr S Bhatia
Scientific

Anaesthetic Dept
Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom

Primary study design	Interventional
Study design	Randomised double-blind controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Does oral diclofenac together with oral paracetamol affect gastric volumes and pH in children?
Study objectives	Does diclofenac/paracetamol given orally pre-operatively together increase gastric contents when compared to paracetamol?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Pre-operative care
Intervention	Diclofenac and paracetamol compared to paracetamol alone
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Diclofenac, paracetamol
Primary outcome measure(s)	Volume and pH of gastric contents at induction
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	20/02/2007

Participant type(s)	Patient
Age group	Child
Lower age limit	2 Years
Upper age limit	15 Years
Sex	All
Target sample size at registration	50
Key inclusion criteria	1. 50 children recruited from Royal London Hospital paediatric wards, aged 2-15 years 2. Elective surgery 3. American Society of Anesthesiologists (ASA) I/II
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	20/04/2003
Date of final enrolment	20/02/2007

Royal London Hospital

London
E1 1BB
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes