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Trial registered on ANZCTR


Registration number
ACTRN12614001194651
Ethics application status
Approved
Date submitted
7/10/2014
Date registered
13/11/2014
Date last updated
13/11/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of prophylactic use of pethidine for anxiety and post procedural pain relief in patients undergoing percutaneous liver biopsy
Scientific title
In patients undergoing percutaneous liver biopsy, do prophylactic use of pethidine, compared to no treatment, reduce the anxiety and post procedural pain relief
Secondary ID [1] 285452 0
Nil
Universal Trial Number (UTN)
U1111-1162-6676
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patient undergoing percutaneous liver biopsy 293222 0
Condition category
Condition code
Anaesthesiology 293490 293490 0 0
Pain management
Oral and Gastrointestinal 293580 293580 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients undergoing percutaneous liver biopsy receive 50mg of intravenous pethidine and 10mg of intravenous metoclopramide as premedication.
Intervention code [1] 290387 0
Treatment: Drugs
Intervention code [2] 290513 0
Prevention
Comparator / control treatment
Patient assigned to placebo group received 1ml of normal saline and 10mg of metoclopramide intravenously
Control group
Placebo

Outcomes
Primary outcome [1] 293313 0
Patients were asked to fill in a Penn State worry questionnaire prior procedure
Timepoint [1] 293313 0
Before the procedure and pre-medication given
Primary outcome [2] 293456 0
Patients were asked to self-evaluate pain experienced using a visual analogue score (0-10)
Timepoint [2] 293456 0
Immediately after the procedure and an hour later
Secondary outcome [1] 310783 0
Patients were follow up by telephone call to assess complications (nausea, vomiting, bleeding, or admission to hospital)
Timepoint [1] 310783 0
24 hours after the procedure
Secondary outcome [2] 311080 0
Patients were asked to give a retrospective pain score of the procedure (0-10)
Timepoint [2] 311080 0
24 hours after the procedure
Secondary outcome [3] 311081 0
Patients were asked their willingness to have a repeat procedure if require
Timepoint [3] 311081 0
24 hours after the procedure

Eligibility
Key inclusion criteria
All patients undergo percutaneous liver biopsy at Dunedin hospital
Minimum age
16 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Patients with previous allergic reaction to pethidine or metoclopramide; 2) Patients with clotting disorders and abnormal prothrombin time with international normalized ratio (INR) of greater than 1.5 or thrombocytopenia with platelet less than 50 x 109 per litre; 3) abdominal ultrasound revealed a contraindication to PLB such as massive ascites, intrahepatic duct dilatation, or focal lesion; 4) patients without a telephone for study follow up; and 5) patients with a solitary lesion that required target biopsy under ultrasound guidance

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An independent nurse who is not involved in the liver biopsy or caring for the patient after the procedure will have a randomised list of numbers and the type of drug ( placebo or pethidine) for each number. She will blind the medication by drawing the assigned medication and cover the syringe with a sticker holding the randomisation number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The sample size was calculated to achieve 80% power to detect a 0.6 (pain score) standard deviation difference with an alpha of 0.05. The two groups were compared by Student t-test or Fisher’s exact test for qualitative variables. A p value of less than 0.05 was considered significant.

Recruitment
Recruitment status
Completed
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 outside Australia
Country [1] 6397 0
New Zealand
State/province [1] 6397 0
Otago

Funding & Sponsors
Funding source category [1] 290061 0
Self funded/Unfunded
Name [1] 290061 0
Address [1] 290061 0
Country [1] 290061 0
Primary sponsor type
Hospital
Name
Gastroenterology unit, Dunedin Hospital
Address
201 Great King St. Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 288749 0
None
Name [1] 288749 0
Address [1] 288749 0
Country [1] 288749 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291765 0
Lower South Regional Ethics Committee
Ethics committee address [1] 291765 0
Ministry of Health
229 Moray Place
PO BOX 5849
Dunedin 9016
Ethics committee country [1] 291765 0
New Zealand
Date submitted for ethics approval [1] 291765 0
Approval date [1] 291765 0
18/09/2008
Ethics approval number [1] 291765 0

Summary
Brief summary
Liver biopsy is an important procedure for the diagnosis and evaluation of liver disease and it can be associated with pain. For years this procedure was performed in Dunedin hospital without Pethidine give prior to the investigation. Two years ago we started giving pethidine immediately before a liver biopsy was performed. This was done to potentially decrease the amount of pain-relief required following the procedure. A recent analysis of our data indicated that this was indeed the case however, an unknown number of patients might have been given Pethidine unnecessarily because they never experienced any pain after the procedure. With this study we would like to assess how effective pre-procedural Pethidine is in controlling pain and anxiety during and after the procedure.
Trial website
None
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 51930 0
Dr Antony Pan
Address 51930 0
Gastroenterology Department
Dunedin Hospital
201 Great King St
Dunedin 9016
Country 51930 0
New Zealand
Phone 51930 0
+64 3 474 0999
Fax 51930 0
Email 51930 0
antonypan@yahoo.com
Contact person for public queries
Name 51931 0
A/Prof Michael Schultz
Address 51931 0
University of Otago
Department of Medical and Surgical Sciences
Dunedin School of Medicine
PO Box 913
Dunedin 9016
Country 51931 0
New Zealand
Phone 51931 0
+64 3 4740999
Fax 51931 0
Email 51931 0
michael.schultz@otago.ac.nz
Contact person for scientific queries
Name 51932 0
A/Prof Michael Schultz
Address 51932 0
University of Otago
Department of Medical and Surgical Sciences
Dunedin School of Medicine
PO Box 913
Dunedin 9016
Country 51932 0
New Zealand
Phone 51932 0
+64 3 4740999
Fax 51932 0
Email 51932 0
michael.schultz@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary