Clinical trial: NCT01516684
Section: Alternatives
Subsections: Are There Benefits To Taking Part In The Study?|What Other Choices Are There?

Based on experience with EMLA cream in other patients, researchers believe it may be of benefit to subjects undergoing lumbar puncture. It is possible that EMLA cream could allow less IV anesthesia medicine to be used to keep you still for the LP. Getting less IV medicine is probably safer than getting more. Because individuals respond differently to therapy, no one can know in advance if it will be helpful in your particular case. You are not expected to receive any other direct benefits from taking part in this research study. We hope the information learned from this study will benefit other people in the future.

You do not have to be in this study to receive treatment. You should talk to your doctor about all the choices you have. Instead of being in this study, your options include: 1. You can choose to have your regularly scheduled lumbar punctures with or without EMLA cream while under sedation in the sedation suite. 2. You can choose to have the lumbar puncture performed without sedation, with or without EMLA cream on the lower back.
Clinical trial: NCT01516684
Section: Confidentiality
Subsections: What About My Health Information?

In this research study, any new information we collect from you about your health or behaviors is considered Protected Health Information. The information we will collect for this research study includes: 1. Total dose of propofol administered to you. 2. Blood pressure during the sedation 3. Amount of movement if any during the sedation. 4. Satisfaction with the sedation. 5. How long it takes you to wake up. 6. Anesthesia time and procedure time. We will make every effort to keep your Protected Health Information private. We will store records of your Protected Health Information in a cabinet in a locked office or on a password protected computer. Only the following people or organizations will be granted access to your Protected Health Information:  
1) The study investigator and his team, or others at Wake Forest Baptist Health who oversee research 2) Other people or laboratories providing services for this research project on behalf of Wake Forest Baptist Health.
If required by law or court order, we might also have to share your Protected Health Information with a judge, law enforcement officer, government agencies, or others. If your Protected Health Information is shared with any of these groups it might no longer be protected by federal or state privacy rules. Any *Protected Health Information* entered into your medical record will be kept for as long as your medical record is kept by the Medical Center. Any *research* information collected from you in this study will be kept in the research records for at least six years after the study is finished. At that time any research information not already in your medical record will either be destroyed or it will be de-identified. You will not be able to obtain a copy of your *research* records until all activities in the study are completely finished. You can tell Dr. Thomas McLean, MD that you want to take away your permission to use and share your Protected Health Information or research information at any time by sending a letter to this address:
Clinical trial: NCT01516684
Section: Duration of Study Involvement
Subsections: How Long Will I Be In The Study?

You will be in the study for only as long as you wish. It could be as short as one day or as long as three years. One randomization and lumbar puncture occurs in one day. You may choose to have more LPs on study after the first one, or you may choose to stop being in the study after the first LP. Most patients with ALL receive about 20 LPs spaced out over 2.5 - 3 years. After that, you will no longer receive protocol therapy but you will still be in the study. Any research information collected from you in this study will be kept in the research records for at least six years after the study is finished. You can stop participating at any time. If you decide to stop participating in the study we encourage you to talk to the investigators or study staff first to learn about any potential health or safety consequences.
Clinical trial: NCT01516684
Section: Participant's Rights
Subsections: What Are My Rights As A Research Study Participant?

Taking part in this study is voluntary. You may choose not to take part or you may leave the study at any time. Refusing to participate or leaving the study will not result in any penalty or loss of benefits to which you are entitled. If you decide to stop participating in the study we encourage you to talk to the investigators or study staff first to learn about any potential health or safety consequences. The investigators also have the right to stop your participation in the study at any time. This could be because it is in your best medical interest, your condition worsened, new information becomes available, you had an unexpected reaction, or because the entire study has been stopped. You will be given any new information we become aware of that would affect your willingness to continue to participate in the study.
Clinical trial: NCT01516684
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Risks Of The Study?|Will You Be Paid For Participating? There Are No Plans To Pay You For Taking Part In This Study. What Happens If You Experience An Injury Or Illness As A Result Of Participating In This Study?

Being in this study involves some risk to you. You should discuss the risk of being in this study with the study staff. Risks and side effects related to the EMLA cream are: Common:
-Rash or Blanching of the skin -Methemoglobinemia - decreased ability of the blood to carry oxygen -Anaphylaxis or Allergic reaction There also may be other side effects that we cannot predict. You should tell the research staff about all the medications, vitamins and supplements you take and any medical conditions you have. This may help avoid side effects, interactions and other risks. The amount of propofol given to each group will be monitored and recorded by the study team. This amount will be increased if there are signs that your child is not receiving adequate sedation. However, your child will never be given a dose that is outside the medical guidelines for safety of this drug. Taking part in this research study may involve providing information that you consider confidential or private. Efforts, such as coding research records, keeping research records secure and allowing only authorized people to have access to research records, will be made to keep your information safe.

Should you experience a physical injury or illness as a direct result of your participation in this study, Wake Forest University School of Medicine maintains limited research insurance coverage for the usual and customary medical fees for reasonable and necessary treatment of such injuries or illnesses. To the extent research insurance coverage is available under this policy the reasonable costs of these necessary medical services will be paid, up to a maximum of $25,000. Wake Forest University Baptist Medical Center holds the insurance policy for this coverage. It provides a maximum of $25,000 coverage for each claim and is limited to a total of $250,000 for all claims in any one year. The Wake Forest University School of Medicine, and the North Carolina Baptist Hospitals, Incorporated do not assume responsibility to pay for these medical services or to provide any other compensation for such injury or illness. Additional information may be obtained from the Medical Center's Director of Risk and Insurance Management. If you are injured, the insurer may require information such as your name, social security number, and date of birth in order to pay for your care. This is because the insurer is required by law to report any payments made to cover the care of any persons who are members of a government insurance plan to the Department of Health and Human Services. You do not give up any legal rights as a research participant by signing this consent form. For more information on medical treatment for research related injuries or to report a study related illness, adverse event, or injury you should call Dr. Thomas McLean.
Clinical trial: NCT01516684
Section: Procedures
Subsections: What Is Involved In The Study?

If you agree to participate and sign the forms, at your study visit you will be randomized into one of the study groups described below. Randomization means that you are put into a group by chance. It is like flipping a coin. You will have an equal chance of being placed in each group. Neither you nor the investigator will know which cream (EMLA or placebo) you are receiving. This is done so that a fair evaluation of results can be made. This information is available to the researchers if needed in an emergency. If you decide to participate in the study, you will only be consented once. You may, however, undergo randomization as many times as you are having an LP done. That means you sometimes might get the placebo cream and sometimes might get EMLA cream. Each LP will require a separate randomization. You will not be asked to consent for the study at each clinic visit. You may stop participating at any time. You may also choose to participate in the randomization process for some LPs but not others. The choice is yours.
Clinical trial: NCT01516684
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

You are scheduled to have a lumbar puncture (LP or "spinal tap"). The purpose of this research study is to see if a skin numbing cream called EMLA (Eutectic Mixture of Local Anesthetic) cream will reduce the amount of total intravenous anesthesia (TIVA) (sleeping medicine) needed to effectively perform an LP. There are concerns among the anesthesia doctors and scientists about the effect of general anesthesia on patients' brains, especially children's brains. We would like to find ways to *reduce* the total amount of intravenous anesthesia administered to patients who require sedation for lumbar puncture, because giving less IV sleeping medicine is safer than giving more in most circumstances. In this study Eutectic Mixture of a Local Anesthetic (EMLA cream) will be compared to placebo cream. A placebo is a substance, like a sugar pill, that is not thought to have any effect on your disease or condition. In this study you will either receive the active study medication (EMLA cream) or placebo cream which is not active. Placebos are used in research studies to see if the drug being studied really does have an effect.