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Trial registered on ANZCTR


Registration number
ACTRN12606000201572
Ethics application status
Not yet submitted
Date submitted
27/02/2006
Date registered
29/05/2006
Date last updated
29/05/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of rate of administration of tramadol on incidence of post operative nausea and vomiting after any surgical operation for which significant postoperative pain is expected
Scientific title
The effect of rate of administration of tramadol on the incidence of post operative nausea and vomiting after any surgical operation for which significant postoperative pain is expected
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post operative nausea and vomiting 1179 0
Condition category
Condition code
Surgery 1262 1262 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
‘Fast’ group – will receive 2.5 mg/kg tramadol (made to 10 ml with addition of saline) intravenously over 2 minutes and 10 ml saline via a syringe driver over 30 minutes.
‘Slow’ group – will receive 10 ml saline over 2 minutes and 2.5 mg/kg tramadol (made to 10 ml with addition of saline) intravenously via a syringe driver over 30 minutes.
Intervention code [1] 924 0
Treatment: Drugs
Comparator / control treatment
‘Placebo’ group – will receive 10 ml saline over 2 minutes and 10 ml saline via syringe driver over 30 minutes.
Control group
Placebo

Outcomes
Primary outcome [1] 1700 0
Comparative peak change from baseline in nausea visual analogue score (VAS) scores between fast, slow and placebo tramadol administration groups
Timepoint [1] 1700 0
Over 3 hours after administration of tramadol/placebo
Secondary outcome [1] 3051 0
Comparative vomiting frequencies, morphine PCA usage, pain scores, duration spent in PACU and patient satisfaction scores between fast, slow and placebo tramadol administration groups over three hours.
Timepoint [1] 3051 0
Measured at time points 0, 0.25, 0.5, 1, 2 and 3 hours after the administration of tramadol or placebo.

Eligibility
Key inclusion criteria
English spoken as first language, or fluent as a second language• Scheduled to have elective non-abdominal surgery under general anaesthesia (including general, orthopaedic, plastic, ENT, urologic, dental or vascular surgery) • Requiring general anaesthesia• Significant post-operative pain requiring opioid therapy expected.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inadequate English comprehension• History of allergy or sensitivity to tramadol or morphine• History of previous episode of significant post operative nausea and vomiting• History of significant motion sickness• Epilepsy• Administration of tramadol within previous 36 hours• American Society of Anaesthesiologists’ (ASA) physical status IV or V, reflecting serious cardiorespiratory co-morbidity.• Currently taking selective serotonin receptor inhibitor, tricyclic antidepressant or monoamine oxidase inhibitor drugs• Currently taking prophylactic antiemetics• Pregnancy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated list
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1380 0
Other Collaborative groups
Name [1] 1380 0
Australian and New Zealand College of Anaesthetists Project Grant
Country [1] 1380 0
Primary sponsor type
Other Collaborative groups
Name
ANZCA (australaian and New Zealand College of Anaesthetists)
Address
Country
Australia
Secondary sponsor category [1] 1216 0
Hospital
Name [1] 1216 0
Melbourne Health
Address [1] 1216 0
Country [1] 1216 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 2732 0
Melbourne Health Ethics Committee
Ethics committee address [1] 2732 0
Ethics committee country [1] 2732 0
Australia
Date submitted for ethics approval [1] 2732 0
Approval date [1] 2732 0
Ethics approval number [1] 2732 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35898 0
Address 35898 0
Country 35898 0
Phone 35898 0
Fax 35898 0
Email 35898 0
Contact person for public queries
Name 10113 0
Sud Agarwal
Address 10113 0
Royal Melbourne Hospital
Parkville
Melbourne VIC 3052
Country 10113 0
Australia
Phone 10113 0
+61 3 93427000
Fax 10113 0
Email 10113 0
malcolm.hogg@mh.org.au and Sud_agarwal@hotmail.com (Please use both is permissible)
Contact person for scientific queries
Name 1041 0
Sud Agarwal and Malcolm Hogg
Address 1041 0
Royal Melbourne Hospital
Parkville
Melbourne VIC 3052
Country 1041 0
Australia
Phone 1041 0
+61 3 93427000
Fax 1041 0
Email 1041 0
malcolm.hogg@mh.org.au and Sud_agarwal@hotmail.com (Please use both is permissible)

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.