What is a Clinical Trial?

Children with life-threatening conditions are often candidates for clinical trials. If your child has a serious illness, your doctor might talk to you about enrolling your child in a clinical trial.

Carefully conducted clinical trials are performed in human participants to provide answers to questions such as:

  • Does a treatment work?
  • Does it work better than the standard existing therapy?
  • Does it have side effects?

“Through clinical trials, doctors find new ways to improve treatments and the quality of life for people with disease. They also give children with rare or difficult-to-treat conditions, such as certain forms of cancer, access to innovative treatments,” says Dr. Van Huynh, a pediatric oncologist at the Hyundai Cancer Institute at CHOC Children’s, and the CHOC principal investigator for the Therapeutic Advances in Childhood Leukemia/Lymphoma Consortium, a group of children’s hospitals and universities that work to quickly develop and carry out clinical trials. The consortium develops phase I and phase II clinical trials of new therapies and novel therapy combinations in recurrent childhood leukemia and lymphoma.

Dr. Van Huynh, a pediatric oncologist at CHOC Children’s.

Clinical trials are standard practice in cancer treatment for children, adolescents and young adults. In fact, a higher percentage of newly diagnosed children with cancer and their families participate in clinical trials, perhaps more than in any other field of medicine, according to Dr. Huyhn. All clinical trials are voluntary and information collected is confidential. Participants can withdraw from a trial at any time, for any reason.

“Some clinical trials evaluate how well new medications work and whether they are safe to use. Other clinical trials explore whether we can use medications in new combinations or at different doses to improve survival or reduce short-term side effects,” says Winnie Stockton, investigational pharmacist at CHOC Children’s. “There are trials that focus on finding the best ways to minimize long-term side effects of certain treatments, and other trials that aim to determine the best dose to give children for medications that have successfully treated cancer in adults.”

Winnie Stockton, an investigational pharmacist at CHOC Children’s

Types of Clinical Trials

Clinical trials are categorized as Phase I to IV trials.

Phase I

Studies of a new drug are the first that involve people. Participants in these trials are usually the first to receive the new therapy. The drug is tested to evaluate the dosages of the treatment and how often the treatment can be administered. Drugs are given at gradually increasing dosages, and participants are monitored closely for side effects. The goal of a Phase I clinical trial is to find the dose that is best tolerated without causing severe side effects.

Phase II

Once a treatment is found to be safe in a Phase I clinical trial, it is then tested in a Phase II trial to determine if it works. The treatment targets the patients who responded most favorably in Phase I trials. In these trials, doctors may evaluate if the treatment works for a specific type of cancer or illness.

Phase III

Once a new therapy has been determined to be safe and effective, it is then moved to a Phase III clinical trial. These are the studies that most children with newly diagnosed illnesses or cancers will receive. These trials test whether the new therapy is better than the standard treatment.

Phase IV (also known as Post-Marketing Surveillance Trials)

Phase IV studies take place after the drug has received regulatory approval (market authorization) and are designed to provide broader effectiveness and safety information about the new medicine in large numbers of patients, and to compare or combine it with other available treatments. These studies are designed to evaluate the long-term effects of the drug.

When you take part in a clinical trial, you will only be in that one phase of the study. Treatments move through the phases, but patients do not.

“At CHOC, we believe it’s important to conduct research directly with children and adolescents in a facility that is devoted exclusively to the care, quality of life, rights and safety of children of all ages. If a parent is interested in having their child participate in a clinical trial, we currently have over 350 research studies in more than 30 specialties to provide children with the latest treatments,” says Dr. Huynh.

Learn more about research at CHOC

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Is Ibuprofen Safe for Kids?

By Kara Lau, clinical pharmacist at CHOC Children’s

Ibuprofen and naproxen are common over-the counter medicines used to treat fever, headache, toothache, muscle pain and inflammation (swelling). Both belong to the class of medicines known as nonsteroidal anti-inflammatory drugs (NSAID).

Ibuprofen, also known as Advil or Motrin, is safe to use in children at least six months of age and older. One dose of ibuprofen lasts approximately six to eight hours.

Naproxen, also known as Aleve, is safe to use in children 12 years and older. However, doctors may prescribe naproxen to younger children for inflammatory diseases such as arthritis. A single dose of naproxen lasts up to 12 hours and therefore requires less frequent doses than ibuprofen.

ibuprofen naproxen dosage guidelines for kids

Download this guide

Although NSAIDs are safe to use when taken as directed, overdoses and misuse can lead to serious problems including kidney failure, low blood pressure and bleeding. Data from the Poison Control Center estimates about 50,000 incidents involving ibuprofen each year.

Here’s what parents can do to ensure their children use ibuprofen and naproxen safely:

Read the product labels carefully.

Dosing can be confusing, so read labels carefully and ask for help from your pediatrician or pharmacist in determining the correct dose. Parents should limit the amount of ibuprofen or naproxen taken per dose and limit the amount taken daily.

Double-check what kind of liquid concentration ibuprofen you have at home.

Liquid ibuprofen comes in varying strengths for infants and children. The U.S. Food and Drug Administration found that confusion over these types led to overdoses that made infants seriously ill.

Again, read labels to know what you have and how much to give to a child.

Use the dosing device included with the medicine.

Kitchen spoons aren’t all the same, and a teaspoon and tablespoon used for cooking won’t measure the same amount as the dosing device. Rely on what’s included with the product to ensure proper dosing.

Check the age restrictions for safe administration.

Read the medication packaging to see if your child is old enough to take ibuprofen or naproxen. Consult your child’s doctor before giving them ibuprofen or naproxen  if your child does not meet the minimum age requirement.

Look for signs of overdose.

Early symptoms of NSAID overdose include vomiting, nausea, abdominal pain, dizziness and tiredness. If a parent suspects their child has overdosed on an NSAID, call poison control immediately at 800-222-1222.

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5 Things You Didn’t Know About Being a Pharmacist

By Michael Shaaw, clinical pharmacist at CHOC Children’s

When most people think about what their pharmacists do at the pharmacy, the first thing that comes to mind might be counting pills. Yes, that is one responsibility of our job, but since pharmacists are one of the most accessible healthcare professional out in the community, here are five facts you might want to know about what we do so that you will be able to get the most out of your encounter with your pharmacist.

It takes a lot of schooling to become a pharmacist

In order to become a pharmacist, one typically would spend about six to eight years in school, including undergraduate course work and obtaining a doctoral degree in pharmacy. In the recent years, many pharmacy school graduates spend an extra one to two years undergoing residency or fellowship training in subspecialty areas such as critical care medicine, emergency medicine, pediatric, geriatric or oncology.

Pharmacists offer many other services beside dispensing your prescription

Aside from filling your prescriptions, a pharmacist can also administer immunizations such as flu vaccines, shingles, and travel vaccines. We can provide medication counseling and medication therapy management to help you better understand and be informed about the medicines that you’re taking in order to better manage your condition. You can also ask a pharmacist for recommendations on over-the-counter products, as well as smoking cessation and other chronic disease monitoring services such as blood pressure and cholesterol levels.

Pharmacists do a lot more than just counting pills

When a pharmacist receives a prescription, he or she will check for any allergy or drug interaction that could potentially do you harm. The pharmacist also makes sure that the dose of the prescribed medicine is appropriate for the stated indication, and raises any concerns to the prescribing physician and provide recommendations when appropriate.

There are pharmacists working in different settings other than retail stores or hospitals

Aside from working in retail or hospital settings, many pharmacists also work in areas such as academia, public health, government, pharmaceutical research, informatics, and managed care. They utilize their knowledge in pharmacology and medicine to further advance our healthcare system.

Pharmacists can save you money

Although pharmacists cannot change your copay set forth by the insurance company, most of the time they can recommend you other medication that’s similar to the one prescribed to you but at a lower cost (such as suggesting a suitable generic in place of a brand name medication). Pharmacists can also provide information about rebates and other cost-saving tips to help lower the cost of the medication

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Know the Dangers of Food and Drug Interactions

By Jennifer Nguyen, clinical pharmacy resident and Grace Lee, clinical pharmacist at CHOC Children’s

Most of us appreciate food for the pleasure of smell and taste, but the food you put in your body, and feed your children, affects far beyond the taste buds. Compounds packed in foods give you energy and provide nutrients to maintain your overall health. However, these compounds also have the potential of interacting with other substances such as medication.

Food and medications can interact at different parts of the body:

  • Absorption: Medications can interact with food when they mix in the stomach. Sometimes this helps the drug get absorbed into the body, but in other cases, medications are blocked from being absorbed and then may be completely ineffective.
  • Metabolism: Foods may affect the levels of proteins in the liver involved with breaking down the drug. This may cause a medication to be metabolized faster or slower than if it was taken alone and influences how long the drug affects the body.
  • Elimination: Ingesting excessive amounts of certain acidic or alkalinic (basic) foods can change the pH levels in the intestines and kidneys, which are organs involved in drug excretion. Changing these environments can speed up or slow down how quickly a drug is eliminated from the body.

Sometimes, the chemical effects of food can enhance or interfere with a medication response. For example, if your child gets a sugar rush from eating sweets while taking a stimulant medication such as Ritalin they may become excessively hyper by this interaction. On the other hand, the side effects from some antibiotics and over-the-counter pain relievers are better tolerated with food in your stomach as a buffer.

Important food and drug interactions you should be aware of for your child are listed in the chart below, organized by food:

Food & Beverages Medications Interaction Symptoms to recognize
Dairy or calcium-fortified juices Some antibiotics:

  • Ciprofloxacin
  • Doxycycline
  • Minocycline
  • Tetracycline
Calcium contained in dairy or juices may decrease antibiotic absorption in the stomach Infection not improving or taking longer to see improvement
Soybean and walnuts

  • Soybean flour can be found in various baby milk formulas
  • Soy is also found in some dietary supplements as a composition of the capsules
  • Levothyroxine
Soybean increases elimination of thyroxine through the gastrointestinal track.   Caution is indicated for patients requiring thyroid hormone therapy Decreased effect of levothyroxine, or low thyroid levels

  • Coffee
  • Soda
  • Teas
  • Chocolate
  • Energy Drinks
Some bronchodilators:

  • Albuterol
  • Theophylline (specifically the once daily, sustained-release formulation)


Some antibiotics:

  • Ciprofloxacin
Caffeine can increase side effects of excitability, nervousness, and rapid heartbeat from bronchodilators by mimicking the same effect

Ciprofloxacin slows the  metabolism of caffeine in the liver leading to increasing effects of caffeine on the body

  • Excitability
  • Nervousness
  • Rapid heart beat
  • High blood pressure
Grapefruit juice
  • Fexofenadine (over-the-counter allergy medicine)


  • Amlodipine
  • Levothyroxine
  • Carbamazepine
  • Statins (Atorvastatin, Lovastatin, and Simvastatin)


  • Amphetamines (Adderall)


Grapefruit juice blocks the absorption of fexofenadine in the stomach

Grapefruit juice slows the breakdown of these drugs in the liver,  leading to  longer duration of drug action and side effects

Acidic juices such as grapefruit juice lessen amphetamine absorption in the small intestine.

  • Decreased effect of antihistamine (more allergy symptoms)
  • Increased carbamazepine levels, leading to dizziness, drowsiness, headache
  • Increased amlodipine side effects increased irregular heart beat
  • Increased statin toxicity includes muscle soreness and dark cola colored urine
  • Less drug effect from Adderall
Tyramine-containing foods:

  • Aged-cheeses
  • Salami, sausages, pepperoni
  • Avocadoes, figs, dried fruits (prunes, raisins)
  • Sauerkraut
  • Soy sauce
  • Caffeine
  • Monoamine Oxidase Inhibitors (MAOIs):
    • Phenelzine
    • Tranylcypromine
    • Selegiline
    • Rasagiline
  • Linezolid
  • Isoniazid (TB medication)
Tyramine increases the release of brain chemicals that can boost your blood pressure.

MAOIs block the breakdown of brain chemicals that also have an effect on blood pressure, leading to an additive effect

Linezolid and isoniazid are also MAOIs, in addition to their other antibiotic effects

Sudden, dangerous increase in  blood pressure
Histamine-containing foods:

  • Tuna
  • Tropical fish
  • Isoniazid
Isoniazid blocks the metabolism of histamine in the body. Increased histamine in the body leads to the same effect as having an allergic reaction
  • Headache
  • Sweating
  • Fast or irregular heart beat
  • Flushing
  • Low blood pressure
Foods with high amount of vitamin K:

  • Brussel sprouts
  • Broccoli
  • Kale
  • Spinach

Cranberry juice

  • Warfarin
Foods high in vitamin K counteract the effects warfarin has on clotting, making it less effective
  • Potential for increased clotting
  • Swelling in one arm or leg (from a blood clot)
  • Non-Steroidal Anti-Inflammatory Drugs (NSAIDs):
    • Ibuprofen
    • Aspirin
NSAIDs can cause side effects such as stomach upset or stomach bleeds. Taking food at the same time can help protect the stomach  Stomach upset relief

While most foods have neutral or minimal effect on drug effect, consult your child’s pediatrician or pharmacist before starting a new medication. The best way to avoid drug-food interactions is to take medication with plain water and space medications at least an hour before or after a meal. If food must be used to mask the taste of medication, consult with a pharmacist to determine what is compatible.

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Is It a Cold, Sinus Infection or Allergies?

By Fionna Lam and Tran Nguyen, clinical pharmacists at CHOC Children’s and Dr. Jonathan Auth, CHOC Children’s pediatrician

With the winter season nearing the end and spring season already here, many of us are experiencing nasal symptoms related to the common cold, a sinus infection, or seasonal allergies. Since all these conditions share overlapping signs such as sneezing, nasal discharge and congestion, distinguishing between them may be the first step to selecting the proper over-the-counter remedy for symptomatic relief.

The common cold usually peaks during cold weather and is caused by a viral infection. While children may feel crummy for a few days, most cold symptoms can be managed with over-the-counter medications. Sinus infections, on the other hand, can bring about headaches and facial pain. It can happen after a prolonged common cold when the body is more vulnerable to bacterial or viral infections. Some children may be more susceptible to sinus infections than others due to structural abnormalities in the nose.

Sneezing, nasal congestion, and/or watery eyes are the hallmark symptoms of seasonal allergies. These are due to the body’s immunologic reaction to irritants in the air. This condition usually peaks during spring time when the highest amount of pollens from trees, grasses or weeds are present in the environment. Other common allergens include dust and mold.

The following table compares some common signs and symptoms of common cold, sinus infections and seasonal allergies:

Symptom Common Cold Sinus Infection Seasonal Allergies
Fever/chills +/- * +/-
Sneezing + +/- +
Stuffy/runny nose + + +
Color/consistency of sinus discharge Clear and watery, or thick and colored Thick, yellowish or greenish Clear and watery
Sore/itchy throat + +/-
Cough + ** +/-**
Chest congestion +
Headache/facial pain +
Stiff neck +
Watery eyes +

+    present

+/-  may or may not be present

*Fever and/or chills are more common in children than adults

**Cough may present if post nasal drip present

It’s important to be aware of how long each symptom has been present. Cold symptoms usually start to show improvement in most children in 7-10 days. Sinus infections usually have longer lasting symptoms without treatment, around 10-14 days. Allergies are usually present for weeks or more.

When an infection or allergy occurs, the blood vessels in your child’s sinuses dilate and the tissues tend to swell up, which can lead to pain around the eyes, cheeks and forehead. Mucus production increases during an infection and can cause further discomfort. Small microscopic hairs in our nose called cilia help sweep bacteria and particles from our nose, but when dry air enters our nose, it can damage the cilia by drying them out.

Before resorting to medications, non-pharmacological strategies can be tried first such as introducing moist air with a humidifier, taking warm showers or drinking hot fluids like tea and soup. Keeping the air moist will help prevent drying out the nose passage and prevent mucus buildup.   Applying a warm compress to the face may also help alleviate congestion pain.

A variety of over-the-counter medications can provide targeted symptomatic relief. See the chart below for active ingredients and their role in cold and sinus infections. Learn what to look for when choosing the right over-the-counter medication for your child. While combination products offer the convenience of addressing many symptoms at once, they often contain more than one ingredient. When multiple over-the-counter remedies are taken together, the risk of toxicity increases due to duplication of active ingredients or doubling up on drugs in the same drug class. For example, acetaminophen (Tylenol) is commonly found in many over-the-counter cold and cough medications. Inadvertent overdoses have occurred when parents gave these medications along with Tylenol. To minimize this risk, single ingredient products are recommended whenever possible. Download this guide to acetaminophen for children.

Remember that over-the counter medications are not completely safe and do come with risk of side effects and toxicity if not taken correctly. Talk to your child’s pediatrician or pharmacist before starting a medication regimen.

Active ingredient Purpose Symptoms Treated
Mucous Cough Pain Fever Runny Nose Stuffy Nose
Acetaminophen Pain reliever + +
Ibuprofen, Naproxen Pain reliever + +
Phenylephrine*, Pseudoephrine* To relieve nasal congestion + +
Dextromethorphan** Cough suppressant +
Guaifenesin To loosen up phlegm + +
Saline spray To relieve nasal congestion + +
Mentholated topical ointment To relieve nasal congestion + +
Fluticasone, Triamcinolone (Nasal Spray) To relieve nasal congestion + +
Oxymetazoline*, Phenylephrine*(Nasal Spray)  To relieve nasal congestion  + +

+ present

*Do not use decongestant for more than 3 days as it might make you more congested.

**Discretion should be used when using dextromethorphan as a cough suppressant as high doses can cause hallucinogenic effects and be abused.

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