A U of A research project that will answer big unknowns about how to safely treat kids who arrive at the hospital in pain is set to get underway.
"Doctors need a more accurate and robust database of information for prescribing many of the medications we use in children," said Samina Ali, a UAlberta pediatric emergency medicine physician who is leading the study.
"For example, we are often making educated guesses on what is the best pain treatment for children who arrive in the ER with injuries, and treatment approaches vary widely by facility and physician. No child should be in pain if they don't have to be," she added.
Ali's NO OUCH research trial was chosen among a select few for inclusion in a unique project called Innovation in Pediatric Clinical Trials (iPCT) based on the most pressing information needs for medical practitioners and Canadian families.
Medical need
"We have solid evidence over three decades that when you don't treat pain well in infants and children, there are long-term biological and psychological changes," she said. These include heightened sensitivity to pain, health-care phobias like fear of needles and either overuse of the health-care system or avoidance.
When children arrive at the emergency, it's actually easier for doctors to diagnose and treat the injury when pain is properly managed, she added.
Currently, doctors prescribe pain medications for children based on manufacturers' instructions or by extrapolating from adult data when child-specific research is missing, explained Ali.
"But there just aren't nearly enough clinical trials on pain medications, or all medications for that matter, in children."
It's difficult to recruit children for clinical trials, but Ali also contended that it hasn't been prioritized among the medical research community.
Health Canada's ban of codeine use for treating pain in children occurred three years ago after deaths resulted from its use, she said, adding that it turns out some children metabolize the drug dangerously quick.
Non-opioid medications most commonly used for children are ibuprofen and acetaminophen.
"Currently, it is unclear what the best oral opioid might be to use for them, and hydromorphone is emerging as an old medication that might have a role in treating children with injuries," said Ali.
The NO OUCH trial will attempt to study these alone and in combination with one another for effectiveness, side effects and adverse reactions, said Ali. Previous research conducted by Ali's team suggests that in some cases non-opioid drugs may be just as effective as opioids while raising fewer parental concerns and causing less side effects.
This pain trial is one among four funded in the iPCT project and being conducted in six pediatric emergency departments across four provinces, said Ali. The other three trials will look at medications for infant breathing problems, stomach flu and sedating for painful fracture treatment.
The long-term goal of the iPCT project is to lay the groundwork for KidsCAN, a Canadian co-ordinating and advisory infrastructure network to make trials for children better and more effective and to ensure best therapies for children, explained Ali.
Parental concern
"Given our country's very serious opioid crisis, it's not surprising that parents are worried about their kids taking opioid medications even when they are in a great deal of pain in the ER," said Ali, adding that there is no current evidence that opioids, when used in appropriate doses in the short-term in kids, result in addiction down the road.
Because caregivers make the decision about whether or not to medicate their child both in hospital and at home after discharge, the NO OUCH research trial into pain medication, already one of the largest of its kind, will also be the first to include parents as research partners.
"We want to understand parent preferences so we can avoid situations where a child goes home and their pain is undertreated," said Ali.
She contended that no child should be left in pain if they don't want to be, and that a philosophy of living with pain "toughens one up" is unfounded.
The Canadian Institutes of Health Research (CIHR) is funding this study along with the Stollery Children's Hospital Foundation (SCHF) through the Women and Children's Health Research Institute (WCHRI), as well as Research Manitoba and the Children's Hospital Foundation of Manitoba.