Assent for ages 8 to 12 Years of Age
The impact of Genotype on Plasma and Cerebral Spinal Fluid Pharmacokinetics of
Celecoxib in Children
Principal Investigator: Dr. Kimmo Murto 613-239-7951
Dept of Anesthesiology
Co-Investigators: Dr. Ahmed El-Alfy 519-729-4100
Dept of Anesthesiology
Cambridge Memorial Hospital
Dr Raveena Ramphal MBChB 613-737-7600 x2987
Division of Hematology/Oncology
Dr. Jackie Halton 613-737-7600 x2370
Division of Hematology/Oncology
Regis Vaillancourt, OMM,CD,B.PharmD,FCSHP 613-737-7600 x2228
Dept of Pharmacy
Dr. Alan Chaput 613-761-4169
Dept of Anesthesiology
The Ottawa Hospital
Coordinators: Kelly-Ann Ramakko, B.SC, CCRC 613-759-0791
Tracy Jackson, CCRP 613-239-6029
Why we would like to speak with you?
We want to talk with you about being a part of something called a research study. A research
study is a way to test new ideas. Research helps us learn new things. Doctors who do
research are also called researchers.
Why am I being asked to be in this research study?
You are being asked to be in this study because you will be having tests while under
anesthesia. The tests may cause headaches or back pain afterwards. We have a medication
that may reduce the amount of this pain. It may also make you generally feel better. In
addition, this medication is special because it might make medications used to fight cancer
work better.
If you have any questions about this study, we want you to ask them at any time.
What is this study about?
We want to know how well a pain medication called celecoxib, enters your body and the fluid
surrounding your brain. We also want to know what dose of the medicine works the best on
patients like you.
What will happen to me?
If you agree to be in the study:
1. You will be given study medicine to drink before and after your tests.
2. You will have some extra blood taken before and after your tests.
3. We will remove a little extra fluid from your back during the tests.
4. Before and after your tests we will ask you and your parents questions about how you
are feeling, your amount of energy, and your level of pain.
5. At bedtime for seven days after your tests you and your parents will be asked to tell us
about your level of pain over the day and if you have noticed anything different about
your body.
This will happen five times, for five tests.
Will this study hurt?
You have an intravenous port under your skin that was placed during an operation. It allows
the nurses to easily give you medications and take blood without extra needle pokes.
Sometimes inserting a needle through the skin over the port may hurt. This study will not
cause you to have any more needle pokes then you would normally have. We will use the
port to take very small samples of your blood to see how much pain medication is in it. The
extra fluid we take from your back will be under anesthesia so it should not cause you any
pain.
What if I don't want to be in the study?
It’s okay to say 'NO' if you don't want to be in the study. No one will be upset with you and the
doctors will still give you the very best care. Also, it is okay to be in the study now and change
your mind at any time before your tests. Talk to your parents/guardians about your decision.
Who should I ask if I have any questions?
If you have any questions about the study, you or your parents can call Dr. Kimmo Murto at
613-737-2431.
Consent Form Version: December 24, 2010, Version #3
Protocol Version: September 17, 2009, Version #2
Protocol: #09/09E-Dr Kimmo Murto/tj
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ASSENT
Do you want to be in the study?
Please check one box:
Yes, I want to be in the study. No, I do not want to be in the study.
Name of Child (Print) Date
Verbal assent
Signature of Child
Name of person obtaining assent (Print)
Signature Date
(If verbal assent obtained the process must be clearly documented in the research or
medical file)
Consent Form Version: December 24, 2010, Version #3
Protocol Version: September 17, 2009, Version #2
Protocol: #09/09E-Dr Kimmo Murto/tj
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