Narcotics Lollipop a. Should the FDA ban the narcotics lollipop? Go through the steps of the linear model to decide how this issue could be resolved.
Define Problem
The problem to be addressed is whether or not the narcotic lollipop should be barred. Answering this question requires consideration of various factors. Questions raised include:
Is the narcotic fentanyl too dangerous for children?
Is the narcotic fentanyl more dangerous than the tranquilizers used?
Is the lollipop as a means of distributing the drug also a problem?
Do doctors make up their own unregulated sedatives to calm children before surgery?
Is the lollipop preferable if the alternative is the unregulated sedatives doctors use?
Is there a problem with controlling the dosage of the drug?
Gather Evidence
Fentanyl is a drug used to treat chronic pain, pain associated with operative procedures and used to enhance general anaesthetics. It is commonly used as a preoperative medication to sedate patients prior to surgery, including being used for children. It is a narcotic in that it is addictive. Fentanyl is also a drug that is used illicitly, with actions similar to heroin, though the drug is around 100 times more potent than heroin. Fentanyl has been approved by the Food and Drug Administration (FDA) and is administered via injection and in lozenge form.
Tranquilizers used in preoperative conditions are mild sedatives, with diazepam the most common. Diazepam is used for preoperative sedation and for light anaesthesia. Diazepam can also be addictive with long-term use and is not recommended to be used for young infants.
Research has reported that the stress a child experiences on the day of surgery is a significant problem, with children experiencing nightmares, sleep and eating disturbances two weeks after the surgery and twenty percent of children experiencing problems six months after the surgery. One study also reports that preoperative sedation significantly reduces the occurrence of these postoperative problems. The same study reports that other non-drug methods such as preparing the child for the experience and having the parent present can be useful (Kain).
Sedation is also commonly used preoperatively, with it most important that the medication be easy to administer and have a rapid onset and offset. The most common preoperative medication for children is midazolam, with around 80% of cases using this drug. Midazolam is taken in oral form, has rapid onset, few side effects and is FDA approved (Kain).
3. Refine Evidence
The evidence collected has shown that reducing stress in the preoperative child is important enough to warrant using medication. The evidence needs to be assessed based on whether it indicates a problem with using fentanyl.
Firstly, fentanyl is approved by the FDA for use in preoperative conditions. This approval suggests that there is not a safety problem associated with fentanyl. Fentanyl also compares with the most commonly used drug, midazolam, in terms of working quickly, being easy for the child to take and having few side effects. Based on this information, there is no indication that fentanyl poses a safety concern. Fentanyl is addictive but with its use as a one-time medication, this fact is not relevant to the safety concerns.
The method of delivering the drug via a lollipop may be an issue of concern, with it worth considering what message this sends to children. However, considering the child does not need to be aware that the lollipop contains a drug, this point does not seem to be of concern.
One issue the research raises is whether fentanyl is a concern because of its narcotic effect. This concern is not associated with the children who use it, but with the question of whether it will lead to illicit drug users using the product for its heroin-like properties.
The other possible problem indicated is the concern over managing the dosage. However, the lozenge or lollipop form is no different from an oral dosage such as a tablet, with the content of the lollipop being known. The dosage is also not critical since it is the sedative effect that is required, an effect that an anaesthetist can observe.
4. Generate Hypotheses
If the preoperative stress children experience is significant, the use of a drug to reduce stress is warranted.
If the drug fentanyl is medically safe for children, its use to reduce stress is warranted.
If the drug fentanyl is for one-off preoperative use, its addictive or narcotic nature is not a concern.
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