Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0192080394
Study information
Scientific title
Acronym
Study hypothesis
What effect does morphine and tramadol administration after surgery using patient controlled analgesia (PCA) have on gastric emptying?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Signs and Symptoms: Gastric emptying
Intervention
Randomised controlled trial.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Maximum plasma concentration (Cmax) for paracetamol
Time to reach maximum plasma concentration (Tmax) for paracetamol
Area under the plasma concentration - time curve (AUC) for paracetamol
Plasma concentrations of morphine, M6G and tramadol
Secondary outcome measures
Not provided at time of registration
Overall trial start date
13/09/1999
Overall trial end date
01/09/2000
Reason abandoned
Eligibility
Participant inclusion criteria
Total number of subjects = 40.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
40
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
13/09/1999
Recruitment end date
01/09/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
c/o Greg Hobbs
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Nottingham University Hospitals 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
1. 1998 comparison results in http://www.ncbi.nlm.nih.gov/pubmed/9706948
Publication citations
-
Comparison results
Crighton IM, Martin PH, Hobbs GJ, Cobby TF, Fletcher AJ, Stewart PD, A comparison of the effects of intravenous tramadol, codeine, and morphine on gastric emptying in human volunteers., Anesth. Analg., 1998, 87, 2, 445-449.