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Informed Consent Form
Celecoxib for Pediatric Adenotonsillectomy: A Randomized Controlled Double Blinded
Study
Principal Investigator:
Co-Investigators:
Coordinators:
Dr. Kimmo Murto, Dept. of Anesthesia
Dr. Johnna MacCormick, Dept. of Otolaryngology
Dr. Regis Vaillancourt, Dept. of Pharmacy
Dr. Christine Lamontagne, Dept. of Anesthesia
Dr. David Rosen, Dept. of Anesthesia
Kelly-Ann Ramakko B.Sc., CCRC
Tracy Jackson CCRP
613-239-7951
613-239-6964
613-719-3442
613-593-4314
613-566-5221
613-759-0791
613-239-6029
Why is this study being done?
You are being asked to take part in a research study about pain relief after the removal of your
child’s tonsils or tonsils and adenoids. This is often referred to as Tonsil and Adenoid (T&A)
surgery. Your child is scheduled to undergo one of these surgeries. There is a 7 in 10 chance
that your child could have moderate to severe pain after the surgery. Standard care for these
surgeries include pain medication provided during surgery, followed by medication in the wake
up room. These medications include morphine and fentanyl. They work well, but can cause
nausea and vomiting, constipation, itchiness and excessive sleepiness. When you go home,
your doctor will prescribe Tylenol and morphine. Anti-inflammatory pain medications such as
ibuprofen (Advil®) for T&A pain is not recommended because they may cause bleeding.
Bleeding may be related to the drug’s effect on platelets (cells in your blood that make blood
clots) making them less “sticky” and unable to form a scab.
Our study is exploring a drug called celecoxib. It is being used with success in the United States
for pain relief in children suffering from inflamed joints. It has some similarities to ibuprofen
(Advil®). However, Celecoxib does not affect platelets in the child’s blood. We hope that
this medication will be an effective pain reliever after surgery. Celecoxib appears to boost
morphine’s effect when given together. This means less morphine would be needed to get the
same amount of pain relief. Less morphine could mean fewer unwanted side effects.
Here at CHEO we routinely give celecoxib to children for pain with good success. Celecoxib has
yet to be officially approved for use among Canadian children. The goal of this study is to
evaluate the risks and benefits of celecoxib. Our study has been approved by Health Canada
and by CHEO’s Research Ethics Board.
Who will be enrolled?
Children ages 2-18 undergoing T&A surgery can be included in this study. They will be excluded
if they have certain drug allergies; take certain drugs; have severe asthma; have moderate to
severe Obstructive Sleep Apnea; have very abnormal liver or kidney function, or a large or small
body size for their age. We hope to enroll 210 children into this study.
Randomization
If you agree to let your child participate, they will be 'randomized' into one of two groups.
Randomization means that you are put into a group by chance. Neither you nor your doctor can
choose the group you will be in. You will have a 1 in 2 chance of being placed in either group.
In addition to the usual pain medications, your child will be randomized to receive a study
medication containing either celecoxib or placebo. Randomization ensures that those receiving
the study medication and those receiving placebo are identical in every other respect. That
way, we can know that any differences that we observe between the two groups are due to
celecoxib and nothing else. A placebo is an inactive substance, which may look like medicine
but contains no medicine - a "sugar pill" with no treatment value. A placebo is used in research
to compare the effects of a given treatment (in this case the drug, celecoxib) against no
treatment at all. Half of the children will receive celecoxib, and the other half will receive
placebo. The placebo contains calcium carbonate, which is the active ingredient found in
Tums®.
Parent’s role
You will be asked to give your child the study medication at home. There will be five doses. If
your child still feels pain, you can give them morphine as prescribed by your doctor. Your can
also use over the counter pain medications (e.g. Tylenol®) or medication to help nausea and
vomiting (e.g. Gravol®). For 14 days after surgery you will not be able to give to your child any
over the counter anti-inflammatory medications (e.g. Advil®) out of concern for bleeding.
We need to record the effect of the study medication on your child’s pain relief and if there are
any side effects. You and your child, if they are 5 years or older, will be asked to fill out a diary
about your experience at home for 1 week after surgery. This will not take more that 5 minutes
of your time each day. A research assistant for the study will be calling you during the first week
to answer any of your questions. Also, you and your child, if they are 5 years of age or older,
will be asked to fill out two short fatigue and quality of life questionnaires on the day of surgery
and 7 days later. You will be given a pre-paid courier envelope to mail the diaries and unused
study medication back to us after day 7.
On the 14th day after surgery you will be sent a satisfaction survey by mail or email. If you have
any concerns about to the medication you are encouraged to contact Dr. Kimmo Murto at 613239-7951.
What are the potential benefits?
We expect that celecoxib will improve pain relief after surgery. Your child may or may not benefit
from taking part in this study. Information we learn will allow us to better manage children’s pain
after surgeries like T&A. If we learned that there was one group of children who clearly
experienced less pain than the other, the study would be stopped.
Consent Form Version: March 08, 2011
Protocol Version: May 26, 2010, Version #6
Protocol: #05/10E-Dr Kimmo Murto\kr
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What are the risks and discomforts?
In addition to standard pain medication, your child will be given a total of six (6) doses of study
medication. We expect few if any side effects. During surgery we will collect 4mL (less than a
teaspoon) of blood from your child’s intravenous. This is to make sure they have a healthy liver
and kidneys. We will also to look at your child’s genetic make-up of how they break down
celecoxib. This is done while your child is asleep so they will not feel any pain. Though
collection blood is not routine, starting an intravenous is routine for this type of surgery.
There is a small risk of a release of information from your research records. Health and research
records have been used against patients and their families. For example, in Canada, insurance
companies may deny insurance to patient’s with a certain illness or those that have a genetic
risk of disease. Your hospital medical records cannot, however, be released unless required or
permitted by law or if you sign a release of information. In this study, we are looking at your
child’s genetic make-up of how they break down celecoxib, testing is not related to a genetic
disease link and therefore we believe that there would be no insurance risks to patients and
their families.The researchers of this study will protect your research records so that your name,
address and phone number will be kept private.
Adults have taken 10 times the usual dose of this type of medication without side effects. Antiinflammatory drugs have been linked to cardiovascular risk after long term use in adult who
already had cardiovascular disease. Cardiovascular risk with celecoxib is small and similar to
that of other traditional anti-inflammatory agents like Advil. Children have taken twice the adult
dose of celecoxib daily for 10 months with no cardiac effects. Your child will only be taking
celecoxib for three days. We have attached a table of uncommon side effects.
By signing this consent form you are in no way waiving your legal rights or releasing the
investigators from their legal and professional responsibilities. In the unlikely event that your
child suffers injury as a direct result of participating in this study, normal legal rules on
compensation will apply. You will be provided with any new information that may affect you
willingness to participate in this study.
Can I withdraw from study?
Your decision to participate or not in this study will not affect the care you receive at CHEO. You
are free to withdraw from the study at any time. There will be no penalty to you or your child.
We will inform you of any new information that might influence your decision to continue to
participate in this research project. To withdraw you will need to contact Dr. Kimmo Murto or
your child’s anesthesiologist at 613-737-2431 or 613-737-2595. Your child can also be
withdrawn by the study investigators.
Token of appreciation
For participating in this study you will be given a parking pass for the day of your child’s surgery.
In addition, following completion of the survey on day 14, you will be enrolled into a draw for a
$100 Montana’s gift certificate.
Consent Form Version: March 08, 2011
Protocol Version: May 26, 2010, Version #6
Protocol: #05/10E-Dr Kimmo Murto\kr
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Confidentiality
Research records and samples will be kept for up to 25 years in a secure area according to the
federal drug regulations, and then will be destroyed. Representatives from Pfizer, Health
Canada and CHEO’s Research Ethics Board can have access to your child’s personal
information. Your child will not be identified in any publication or presentation of this study.
The CHEO Research Ethics Board (REB) is a committee of the hospital that includes individuals
from different professional backgrounds. The Board reviews all research that takes place at the
hospital. Its goal is to ensure the rights and welfare of people participating in research. The
Board’s work is not intended to replace a parent or child’s judgment about what decisions and
choices are best for them. You may contact the Chair of the Research Ethics Board (REB) for
information regarding patient’s rights in research studies at 613-737-7600 (x3272). However,
this individual will not be able to provide any health-related information about the study.
If you have any other questions or concerns please feel free to let us know. We would be more
than happy to provide you with any additional information to help you with your decision.
Consent Form Version: March 08, 2011
Protocol Version: May 26, 2010, Version #6
Protocol: #05/10E-Dr Kimmo Murto\kr
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Consent to Participate in Research
I understand that I am being asked to participate in a research study and have had the chance
to have my questions about the study answered. This study has been explained to me by
____________________
___.
I have read all 5 pages of this document and understand this Consent Form. All my questions
at this time have been answered to my satisfaction. If I have any questions about this study, I
may contact Dr. Kimmo Murto at 613-239-7951. I will receive a signed copy of this Consent
Form.
I hereby give consent for my child___________________________ to participate in the study.
_________________________________
Parent/guardian’s Name
______________________________
Child’s Name
_________________________________
Parent/guardian’s Signature
_____________________________
Child's Signature (if applicable)
__________________________________
Date
______________________________
Time
I have explained the study to the patient and parent and believe that they have understood it, to
the best of their knowledge.
__________________________________
Name of Investigator/Delegate
______________________________
Date
__________________________________
Signature of Investigator/Delegate
______________________________
Time
If you wish, you will be provided with a summary of the results at the end of the study.
__ Yes, send me a summary of the results at the end of the study.
__ No, I do not wish to receive a summary of the results at the end of the study.
The blood samples gathered for this study are to be used to understand the break down of
celecoxib in the body. We would like your permission to use any remaining blood obtained from
your child to answer related research questions.
__ Yes, you may use any remaining blood to answer related research questions.
__ No, you may not use any remaining blood to answer related research questions.
Consent Form Version: March 08, 2011
Protocol Version: May 26, 2010, Version #6
Protocol: #05/10E-Dr Kimmo Murto\kr
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ATTACHMENT I: Flow diagram of Study Procedures.

Children Scheduled for T&A Surgery
Given information about study and have the opportunity to ask questions
1.
2.
3.
4.
Day of Surgery
Parent sign informed consent form after all questions have been answered
Children ages 8-15 sign assent form
Parents fill out questionnaire and receive study diary
Children ages 5-18 will fill out a children’s study diary
Celecoxib
 Oral celecoxib given before surgery
Placebo
 Oral placebo given before surgery
During Surgery
1. Blood drawn to check for healthy liver and kidneys and to test how celecoxib is
broken down in the body.
2. Standard anesthesia and pain management for all children
Discharge
1. Child sent home with morphine to take if needed
2. Allowed to take over the counter acetaminophen (Tylenol®) and dimenhydrinate
(Gravol®) as needed
For 2 days after Surgery
1. Child given study medication at home starting on the night of surgery – am and
pm doses
For 1 week after Surgery
Once daily:
1. Parents fill out study diary
2. Children ages 5-18 will fill out a children’s study diary
Day 7 after Surgery
A report of the past 7 days:
1. Parents fill out study diary
2. Children ages 5-18 will fill out a children’s study diary
3. Parents mail completed diaries and left over study medication to CHEO
Day 14 after Surgery
1. Satisfaction survey sent by mail or email
Consent Form Version: March 08, 2011
Protocol Version: May 26, 2010, Version #6
Protocol: #05/10E-Dr Kimmo Murto\kr
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Attachment II: Risks and Side Effects in Children.
Common
Side Effects
Uncommon
Side Effects
Rare Side
Effects
Rare Side
Effects
(Serious)
Celecoxib (Celebrex®)
(# per 100 children unless otherwise
indicated)
May mask a fever in a child with an
infection (15-100)
Ibuprofen (Advil®)
(# per 100 children unless otherwise
indicated)
May mask a fever in a child with an
infection (15-100)
 Headache (<14)
 Stomach ache or acid stomach (<9)
 Fever (<9)
 Nausea (<8)
 Sore throat, inflammation of the sinuses
and/or runny nose (<7)
 Diarrhea (<6)
 Mild skin rash (<3)
 Dizziness (<2)
 Severe cardiovascular events (heart
attack and stroke).
 Has not been seen in children
 With long term use.
 Headache (<3)
 Stomach ache or acid stomach (<9)
 Fever (0)
 Nausea (<9)
 Sore throat, inflammation of the sinuses
and/or runny nose (0)
 Diarrhea (<3)
 Mild skin rash (<9)
 Dizziness (<9)
 Severe cardiovascular events (heart
attack and stroke).
 Has not been seen in children
 With long term use.
 GI Tract or stomach bleeding (1/1000)
 With long term use.
 GI Tract or stomach bleeding (1/1000)
 With long term use.
 Severe allergic reaction (1/1000)
 Severe allergic reaction (1/1000)
 Shortness of breath, rapid heart
 Shortness of breath, rapid heart
rate, fluid build-up in/under the
rate, fluid build-up in/under the
skin, throat and tongue and fever.
skin, throat and tongue and fever.
 Can be life threatening
 Can be life threatening
 Severe rashes (1/1000)
 Severe rashes (1/1000)
 Can affect the skin and mucous
 Can affect the skin and mucous
membranes and can be life
membranes and can be life
threatening
threatening
 Inflammation or damage to the liver  Inflammation or damage to the liver
(1/1000)
(1/1000)
 Causes the skin to turn yellow.
 Causes the skin to turn yellow.
 Can be severe and life-threatening
 Can be severe and life-threatening
 Severe damage to the kidney (1/1000)  Severe damage to the kidney (1/1000)
 May be irreversible and lead to
 May be irreversible and lead to
kidney failure
kidney failure
Consent Form Version: March 08, 2011
Protocol Version: May 26, 2010, Version #6
Protocol: #05/10E-Dr Kimmo Murto\kr
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