Children’s Healthcare of Atlanta
Consent to be in a Research Study
Title: Gabapentin Premedication for Pediatric Anterior Cruciate Ligament Reconstruction: A Randomized
Controlled Trial
Principal Investigator: David J. Nusz, MD
Sponsor’s Name: Emory+Children’s Center for Clinical and Translational Research
If this form is being read by the parent or legal guardian, the term “you” refers to “your child.”
You are being asked to be in a research study. It is entirely your choice. In order to decide whether or not you
want to be a part of this study, it is important that you read and understand this form. It is also important that you
ask any questions that you may have and that you understand all the information in this form. This process is
called “informed consent.”
Why is this study being done?
The purpose of this study is to determine if a one-time dose of gabapentin given before surgery reduces pain after
surgery compared to a placebo (“sugar pill”, or inactive drug) in adolescent patients undergoing ACL surgery. Your
child is being asked to participate because he/she is scheduled to have an ACL reconstruction at Meridian Mark
with Dr. Busch. Gabapentin is FDA approved to treat children with seizures. It is also approved for certain kinds of
pain relief in adults. The use of this drug in this study is considered experimental. In other words, it is not FDA
approved for pain relief in pediatric ACL patients. The anticipated number of participants for this study will be
approximately 100 patients.
What will happen to you in this study?
Your child will be randomly selected to receive either a one-time dose of gabapentin (study drug) or a placebo
(sugar pill), to be taken by mouth, before having ACL surgery. Random selection is like flipping a coin to see which
choice will receive, the gabapentin or the placebo, that does not contain a drug. It is important for you to know
your child will receive all routine or customary pain medications both during and after the ACL surgery. The
gabapentin or placebo will only be given one time before surgery. You will also be asked to take 2 surveys and
complete a pain diary at home. The diary can be returned by mail in the pre-addressed/stamped envelope
provided.
How long will you be in this study?
The study begins right before your surgery, and will continue for five days. After discharge, you will receive a
phone call at 24 and 48 hours and will be asked to briefly describe your pain, any side effects, pain medication use
and knee function. These calls will last around 5 minutes. In addition, you will be asked to complete a diary each
day which will take around 5 minutes per day.
What are the possible risks to being in this study?
Gabapentin is generally well tolerated with few serious adverse effects. However, potential adverse events could
include excessive sleepiness, dizziness, lack of muscle control, fatigue and more seriously, seizures. You will be
closely monitored for these side effects.
What are the possible benefits of being in this study?
Possible benefits for you could include access to a potentially beneficial intervention to reduce pain after ACL
surgery. Information gained about this drug, if found effective for pain relief, may also benefit future pediatric ACL
patients.
CHOA IRB#:
Children’s IRB Approval Date:
Children’s IRB Expiration Date:
Informed Consent Template, Version 10-2-2012
What are the alternatives to being in this study?
The alternative is not to participate in the study. Your child will receive the routine/customary pain medications
during and after the ACL surgery whether or not your child participates in the study.
What is the cost of being in this study?
There is no cost for being in the study. Your insurance company will be billed for your usual medical care. The cost
of the study drug is being paid for by grant funding. Upon completion and return of the pain diary at the end of the
study, your child will receive a $25 gift card for participation in the study.
What if you are injured while in this study?
We will arrange for emergency care or medical treatment if you are injured by this research. No further money
has been set aside by Children’s Healthcare of Atlanta, Inc. other than what your insurance carrier may provide.
For more information about risks or if you believe you have been injured by this research, you should contact Dr.
David Nusz, at 404-785-2008
What if there is new information about this study?
If new information is received during the study that could influence your decision to participate, we inform you
and your child.
What if you have any questions or problems while in this study?
If you have any questions, concerns or complaints about this study call Dr. David Nusz, at 404-785-2008. If you
have any questions, concerns or complaints about your rights as a participant in this study, or would like to obtain
information, or offer input, you can call the Children’s Healthcare of Atlanta Institutional Review Board (IRB) at
(404) 785-7477. The IRB is a committee of people that approves all research in this hospital and follows all the
rules and regulations made by government agencies about how research is done.
Who will be able to see your records of study participation?
Your records of participation in this study are not accessible to the general public and every effort will be made to
maintain confidentiality. However, all records may be subject to subpoena by a court of law. Information that
may be gained from this study will be used only for research and educational purposes. Information may be
published in medical journals with permission of the Principal Investigator, Dr. David Nusz, but your identity will
not be revealed or written in a way that you can be recognized. Additionally, identifying information will be
available to people from the Children’s Healthcare of Atlanta IRB, the Research Compliance Manager, the Office for
Human Research Protections, the Sponsor(s), and the Food and Drug Administration.
A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by U.S.
law. This Web site will not include information that can identify you. At most, the web site will include a
summary of the results. You can search this web site at any time.
What are your rights as a study participant?
Taking part in this study is completely voluntary. You may choose not to take part in this study. If you take part in
this study, you may stop being in the study at any time. Your decision to join or not to join the study will not affect
your current or future medical care at Children’s. If you or your child chooses to drop out of the study, please
notify Dr. David Nusz at 404-785-2008.
Dr. Nusz may stop your child from taking part in this study for any of the following reasons: (1) it would be
dangerous for your child to continue; (2) your child does not follow study procedures; or (3) the study sponsor
decides to end the study.
CHOA IRB#:
Children’s IRB Approval Date:
Children’s IRB Expiration Date:
Informed Consent Template, Version 10-2-2012
Your signature below indicates that you have read this informed consent form and understand its meaning, you
have been given the chance to ask questions and have had those questions answered to your satisfaction, and you
voluntarily agree to allow your child to participate in this study and sign this informed consent form. You will be
given a copy of the signed informed consent form.
Printed Name of Research Subject
Age
Date of Birth
Signature of Research Subject
Date
Time
(Required unless research subject is under the age of 18 years and assent was not obtained for reason
provided below)
Signature of Research Subject’s Parent/Legal Guardian
(Required for research subjects under the age of 18 years)
Signature of Person Obtaining Assent/Consent/Permission
Signature of Interpreter (if applicable)
Date
Time
Date
Date
Time
Time
 The child is 5 years of age or younger and assent is not required for participation in this research
study.
 The child is between the ages of 6-10 years old and has been verbally assented to participate in this
research study.
 In my opinion, the child is not able to assent to participate in this research study for the following
reason:
Signature of Person Obtaining Assent/Consent/Permission
Date
Time
CHOA IRB#:
Children’s IRB Approval Date:
Children’s IRB Expiration Date:
Informed Consent Template, Version 10-2-2012