Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0205128931
Study information
Scientific title
Does oral diclofenac together with oral paracetamol affect gastric volumes and pH in children?
Acronym
Study hypothesis
Does diclofenac/paracetamol given orally pre-operatively together increase gastric contents when compared to paracetamol?
Ethics approval
Not provided at time of registration
Study design
Randomised double-blind controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Surgery: Pre-operative care
Intervention
Diclofenac and paracetamol compared to paracetamol alone
Intervention type
Drug
Phase
Not Applicable
Drug names
Diclofenac, paracetamol
Primary outcome measures
Volume and pH of gastric contents at induction
Secondary outcome measures
Not provided at time of registration
Overall trial start date
20/04/2003
Overall trial end date
20/02/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
50
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
20/04/2003
Recruitment end date
20/02/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal London Hospital
London
E1 1BB
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Barts and The London NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary