Two Practices to Adopt After Pediatric Opioid Trial Halted

By Michael Wong, JD (Executive Director, Physician-Patient Alliance for Health & Safety)

With more than 500,000 pediatric tonsillectomies performed each year in the United States, removal of tonsils is one of the most common surgeries performed on children. According to the American Academy of Otolaryngology Head and Neck Surgery, tonsillectomy is performed 20 percent for infection and 80 percent for obstructive sleep apnea.

(for more on opioids and patent safety, please see click on the picture)

Children undergoing tonsillectomy with or without adenoidectomy are routinely given morphine to manage their pain following surgery. This standard practice of using morphine is being called into question by a recent study conducted by the Motherisk Program at The Hospital for Sick Children (SickKids) and by McMaster University and McMaster Children’s Hospital.

The study results were published in the January 2015 issue of Pediatrics, after the study’s Drug Safety Monitoring Board halted the trial following an interim analysis which strongly demonstrated a high degree of risk of respiratory compromise associated with the use of morphine. One child even suffered a life-threatening adverse drug reaction including oxygen desaturation after being treated with morphine.

What lessons can be learned from this trial?

1. Opioids Should be Prescribed Cautiously, not Routinely

Study co-author Doron Sommer, MD (Clinical Professor of Surgery, McMaster’s Michael G. DeGroote School of Medicine; surgeon, McMaster Children’s Hospital) explained:

These results should prompt clinicians to re-evaluate their post-tonsillectomy pain treatment regimen. Due to the unpredictable respiratory side-effects of morphine, its use as a first-line treatment with current dosage ranges should be discontinued for outpatient tonsillectomy.

The study found that using Ibuprofen in combination with acetaminophen provides safe and effective analgesia in children. As fellow researcher Gideon Koren, MD, FRCPC (Director, Motherisk Program; Senior Scientist, SickKids) said,

The good news is that we now have evidence that indicates ibuprofen is safe for these kids, and is just as effective in controlling their pain, so there’s a good alternative available for clinicians to prescribe.

2If Opioids are Prescribed, Patients Should be Monitored

The Joint Commission cautions that an opioid analgesic like morphine, although usually safe, may be associated with adverse effects, the most serious being respiratory depression preceded by sedation.

EurekAlert! reports that at “both SickKids and McMaster Children’s Hospital, the use of morphine for post-operative pain from pediatric tonsillectomy is reserved for exceptional cases where it is deemed necessary and safe with appropriate monitoring.”

What should the “appropriate monitoring” be?

The National Coalition to Promote Continuous Monitoring of Patients on Opioids recently had its inaugural meeting. The goal of the Coalition is “to establish the business case, demonstrating strong financial justification and improved patient outcomes, and to educate and encourage hospitals to adopt continuous monitoring for all patients on opioids.”

Co-conveners of the Coalition’s inaugural meeting included The Joint Commission, The Anesthesia Patient Safety Foundation, the Institute for Safe Medication Practices, the National Patient Safety Foundation, and the VA National Center for Patient Safety.

The Physician-Patient Alliance for Health & Safety, also a co-convener, recently issued this statement in support of the objectives of the National Coalition to Promote Continuous Monitoring of Patients on Opioids:

To improve patient safety and save patients’ lives, we recommend adopting continuous respiratory monitoring of all patients receiving opioids with pulse oximetry for oxygenation and with capnography for adequacy of ventilation to improve timely recognition of respiratory depression, decompensation or clinical deterioration.

Concludes Gina Pugliese, RN, MS (Vice president, Premier Safety Institute):

We need to promote the safe and responsible use of opioids. One place to start is with common procedures like tonsillectomies. The Motherisk Program shows us that opioids can be safely and effectively be replaced with non-opioid alternatives. That said, if opioids must be used, to prevent respiratory depression and improve safety, patients receiving opioids should be continuously electronically monitored.


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