Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000919415
Ethics application status
Approved
Date submitted
3/04/2016
Date registered
11/07/2016
Date last updated
16/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Use of Patient Controlled Analgesics in the management of pain in Orthognathic Surgery – A randomised controlled trial pilot study
Scientific title
Use of Patient Controlled Analgesics in the management of pain in Orthognathic Surgery – A randomised controlled trial pilot study
Secondary ID [1] 288920 0
None
Universal Trial Number (UTN)
U1111-1181-3681
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post surgery pain management 298255 0
Condition category
Condition code
Anaesthesiology 298400 298400 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following orthognathic surgery (corrective jaw surgery), patients are randomised into control group and exposure group.
The exposure group will be administered a Patient Controlled Analgesics (PCA) on top of their regular pain relief.
The patients in the PCA group will follow the PCA protocol of 100microgram of fentanyl per delivery with a lock out time of 5 minutes. The patient will be given a push button which is connected to the PCA machine. At each press of the button, the machine will deliver 100micrograms of fentanyl. with a lock out time of 5 minutes. This means that patient will receive 12 doses of 100 micrograms of fentanyl per hour. There are no limits on the dosing per day.
The regular pain medications will be Paracetamol 1g every 6 hours, Ibuprofen 400mg every 6 hours or Celebrex 100mg every 12 hours. These medications will be given as tablets.
The PCA and oral pain relief will be administered until patient is discharged
Intervention code [1] 294383 0
Treatment: Drugs
Comparator / control treatment
Following orthognathic surgery (corrective jaw surgery), patients are randomised into control group and exposure group.
The control group will only receive oral pain relief administered orally by the nursing staff.
This includes Paracetamol 1gram every 6 hourly, Ibuprofen 400mg every 8 hourly or Celebrex 100mg every 12 hours, Tramadol immediate release 100mg every 6 hours (with maximum of 400mg per 24hr) as required (PRN), and Oxynorm 5mg every 4 hours as requried (PRN).
These medications will be given until discharge. These patients will be discharged on Paracetamol 1g every 6 hours for 7 days, Ibuprofen 400mg every 8 hours for 7 days and oxynorm 5mg every 4 hours for 3 days.
Control group
Active

Outcomes
Primary outcome [1] 297875 0
Length of hospital stay from the day of surgery to discharge from hospital.
This outcome is assessed by the way of review of medical records
Timepoint [1] 297875 0
The outcome is assessed after the patient is discharge from the hospital
Primary outcome [2] 297876 0
Visual analogue pain score
Timepoint [2] 297876 0
Pain score is measured from 8am the day after surgery and is measured every hour until patient is discharged
Secondary outcome [1] 322501 0
Health economics - the cost of hospital stay for each patient, cost of using patient controlled analgesias. This will involve the review of medical records on how many days patient has stayed post surgery and the amount of patient controlled analgesics used during the post operative period.
The analysis required for the health economics will involve cost-minimization analysis, cost–benefit analysis and cost-effectiveness analysis
Timepoint [1] 322501 0
Assessed after the patient is discharged

Eligibility
Key inclusion criteria
Sample group will be ASA 1 or 2 patients who have no significant prior medical problems (including any cardiac history, respiratory disease, chronic pain issues or on any regular pain relief for chronic pain or arthritic pains) and are having Orthognathic surgery will be recruited for this study. All ages and genders are included. They will be fully informed and given the option to agree or deny participation into the study and will be consented for this study.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
ASA 3, ASA 4, ASA 5
Chronic pain
Fibromyalgia
Syndromic

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)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software from https://www.sealedenvelope.com
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed with Intention to treat analysis
This is a pilot study, therefore will fulfil ethics approval requirement of involving 40 patients in the trial.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/04/2015
Date of last participant enrolment
Anticipated
1/08/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 5542 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 5543 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 13018 0
6000 - Perth
Recruitment postcode(s) [2] 13019 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 293269 0
Hospital
Name [1] 293269 0
Royal Perth Hospital
Country [1] 293269 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
197 Wellington St
Perth 6000
Western Australia
Country
Australia
Secondary sponsor category [1] 292799 0
Hospital
Name [1] 292799 0
Fiona Stanley Hospital
Address [1] 292799 0
Department of Oral and Maxillofacial Surgery
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch 6150
Western Australia
Country [1] 292799 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294747 0
Government of Western Australia Department of Health South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 294747 0
Ethics committee country [1] 294747 0
Australia
Date submitted for ethics approval [1] 294747 0
01/10/2013
Approval date [1] 294747 0
16/10/2013
Ethics approval number [1] 294747 0
13/88

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 823 823 0 0
/AnzctrAttachments/370417-Pain flowchart 4.3.jpg

Contacts
Principal investigator
Name 64726 0
Dr Frank Chang
Address 64726 0
Department of Oral and Maxillofacial Surgery
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch 6150
Western Australia
Country 64726 0
Australia
Phone 64726 0
+61405981551
Fax 64726 0
Email 64726 0
[email protected]
Contact person for public queries
Name 64727 0
Frank Chang
Address 64727 0
Department of Oral and Maxillofacial Surgery
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch 6150
Western Australia
Country 64727 0
Australia
Phone 64727 0
+61405981551
Fax 64727 0
Email 64727 0
[email protected]
Contact person for scientific queries
Name 64728 0
Frank Chang
Address 64728 0
Department of Oral and Maxillofacial Surgery
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch 6150
Western Australia
Country 64728 0
Australia
Phone 64728 0
+61405981551
Fax 64728 0
Email 64728 0
[email protected]

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

Documents added automatically
No additional documents have been identified.