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Trial registered on ANZCTR


Registration number
ACTRN12613000600741
Ethics application status
Approved
Date submitted
30/04/2013
Date registered
27/05/2013
Date last updated
7/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Post tonsillectomy pain control – a double blinded , randomised, prospective study
Scientific title
Does the use of COX-2 inhibitors Celecoxib (Celebrex(Trademark) improve the outcome of post tonsillectomy pain? A double-blinded randomised control study in patients over 18 years of age.
Secondary ID [1] 282420 0
Nil
Universal Trial Number (UTN)
U1111-1142-4978
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tonsillitis 289013 0
Condition category
Condition code
Surgery 289352 289352 0 0
Other surgery
Anaesthesiology 289381 289381 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The administration of a non-steroidal anti-inflammatory drugs, celecoxib,( Celebrex(trademark)) , for the control of post tonsillectomy pain
Post operatively, patients will receive regular analgesics routinely given to post tonsillectomy patients. with allowance for IV Morphine as rescue analgesia, Ondansetron / Maxalon Metoclopramide (taken orally) as antiemetic and other medications deemed necessary..
2 doses of IV Dexamethasone 8mg will be given to all patients post-operatively and on the first morning post surgery.
Upon discharge patients will be supplied with a treatment or placebo pack. Both packs contain
Paracetamol (1gm (4 times per day) 12 days), Penicillin (500mg (twice per day) 5 days), endone (5mg (as required) /6 hrly) and either Placebo (2 capsules (twice per day) 7 days) OR Celecoxib ((200 mg capsules), 2 capsules (twice per day), 7 days)). All medications are taken orally
Study participants will be asked to return all unused medications to the study coordinator at the final outpatient appointment. These will be checked against their patient drug diary to ensure protocol adherence.
Intervention code [1] 287056 0
Treatment: Drugs
Comparator / control treatment
Placebo - lactose powder filled capsule
Control group
Placebo

Outcomes
Primary outcome [1] 289463 0
Is Celecoxib a useful adjunct in post tonsillectomy pain control? Assessed using all the outcomes listed
Pain is scored using a 1 - 10 numeric scale (0 being no pain and 10 being worst pain) recorded in a patient diary. The diary is completed at the same time everyday (at the time of the evening meal) and is assessed when resting, drinking and eating.
Timepoint [1] 289463 0
28 days
Primary outcome [2] 289464 0
Does Celecoxib have more incidence of post tonsillectomy haemorrhage?
Measured on a 3 point haemorrhage scale
1. No bleeding
2. Minimal bleeding - managed medically with no blood transfusion
3. Profuse bleeding - requiring theatre admission or blood transfusion
Timepoint [2] 289464 0
28 days
Primary outcome [3] 289498 0
Is the pain free day earlier in the drug or placebo group? Pain free day is the day when the patient scores the pain as a zero in their patient diary.
Timepoint [3] 289498 0
28 days
Secondary outcome [1] 302546 0
Is the readmission rate for dehydration or poor oral intake lower in the study group
Timepoint [1] 302546 0
28 days
Secondary outcome [2] 302547 0
Does the study group have less side effects e.g. Nausea, vomiting, constipation, drowsiness
Study participants are given a patient diary and asked to specify all side effects experienced
Timepoint [2] 302547 0
28 days
Secondary outcome [3] 302548 0
Does the study group take less rescue analgesics. This will be recorded in a diary given to all study participants.
Timepoint [3] 302548 0
28 days

Eligibility
Key inclusion criteria
Over 18 years
Undergone a tonsillectomy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Other concomitant surgical procedures
(2) Allergic to NSAIDS/opioids/codeine/endone/paracetamol/sulphonamide
(3) Asthma
(4) Kidney disease
(5) Liver disease
(6) Cardiovascular disease
(7) Hemorrhagic disease
(8) Hypertension
(9) OSA
(10) Women trying to conceive, pregnant or nursing
(11) Patients taking clebrex

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)
Patients suitable for the trial will be invited to participate and consented appropriately. Drug allocation will be done by the pharmacist and both the patient and the research personnel will be blinded to allocation.
The drug regime includes Celecoxib (or placebo), paracetamol, endone (rescue analgesic), penicillin
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software to generate a randomisation table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2013
Actual
20/06/2013
Date of last participant enrolment
Anticipated
30/06/2015
Actual
29/04/2015
Date of last data collection
Anticipated
Actual
8/10/2015
Sample size
Target
80
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 957 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 6810 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 287193 0
Hospital
Name [1] 287193 0
Department of Surgery
Frankston Hospital
Country [1] 287193 0
Australia
Primary sponsor type
Hospital
Name
Department of Surgery Frankston Hospital
Address
PO Box 52
Frankston VIC 3199
Country
Australia
Secondary sponsor category [1] 285957 0
None
Name [1] 285957 0
Address [1] 285957 0
Country [1] 285957 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289187 0
Peninsula Health Human Research Ethics Committee
Ethics committee address [1] 289187 0
c/- Research program
Mount Eliza Centre
Jackson Road
Mount Eliza VIC 3930
Ethics committee country [1] 289187 0
Australia
Date submitted for ethics approval [1] 289187 0
Approval date [1] 289187 0
06/06/2013
Ethics approval number [1] 289187 0
HREC/12/PH/55

Summary
Brief summary
This study looks at the treatment of post tonsillectomy pain. The pain experienced is severe and has a tendency to get worse five to seven days after surgery. This often has an impact on the patient’s oral intake prolonging the return to normal activity. The narcotics given for pain control are often associated with side effects.

Non-steroidal anti-inflammatory drugs, such as Celecoxib (Celebrex(trademark) are superior for the control of pain minus the side effects. In this study the patient will be randomised to one of two groups and given a study pack on discharge. Both packs contain an antibiotic (Penicillin) and a “rescue” analgesic (Oxycodone - Endone(Trademark) ). One pack contains paracetamol and one contains paracetamol and Celecoxib/Celebrex.

Patients will be asked to chart their recovery until their pain ceases. A data collection chart will be given to each patient on discharge. Each patient will be followed up in outpatients 5 days and 4 weeks post-surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39670 0
Dr Diamanti Diamantaras
Address 39670 0
Department of Surgery
Frankston Hospital
PO Box 52
Frankston VIC 3199
Country 39670 0
Australia
Phone 39670 0
61 3 97847777
Fax 39670 0
Email 39670 0
[email protected]
Contact person for public queries
Name 39671 0
Lee-Anne Clavarino
Address 39671 0
Research Department
Peninsula Health
Mount Eliza Centre
Jacksons Road
Mount Eliza VIC 3930
Country 39671 0
Australia
Phone 39671 0
61 3 97881473
Fax 39671 0
Email 39671 0
[email protected]
Contact person for scientific queries
Name 39672 0
Francis Ng
Address 39672 0
Department of Surgery
Frankston Hospital
PO Box 52
Frankston VIC 3199
Country 39672 0
Australia
Phone 39672 0
61 3 97847777
Fax 39672 0
Email 39672 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIs celecoxib a useful adjunct in the treatment of post-tonsillectomy pain in the adult population? A randomised, double-blind, placebo-controlled study.2017https://dx.doi.org/10.1017/S0022215116009476
N.B. These documents automatically identified may not have been verified by the study sponsor.