Reader response

Myron Yaster MD

From Elliot Krane, MD, FAAP, FASA, Professor (emeritus ), Stanford University School of Medicine

I’m old enough to remember the day ketorolac became available for children. I was at the Seattle Children’s Hospital, and as a nascent pedi pain doc was enthusiastic about using it. 

So the very next day I found myself assigned to the “tonsil room,” and I administered every patient 0.5mg/kg after induction and IV placement. The ENT surgeon did 7 or 8 cases (private practice, no resident!) and at the end of the day he thanked me, but said he didn’t understand what had happened that day, he struggled to achieve adequate hemostasis on every single patient.  I kept my mouth shut.  

Three days later one of the patients returned to the OR for bleeding.  Obviously that was the end of my using ketorolac for routine T&A’s.  

While realizing that “data is not the plural of anecdote,” that experience (which was really an ad hoc single-blinded qualitative study) convinced and still convinces me that ketorolac has no place in routine T&A’s, at least, not preop and/or at that dose. So don’t confuse me with subsequent controlled studies that say otherwise. Absence of evidence is not evidence of absence. 

On the other hand, it did work great for post T&A pain that day!

From Vikas O'Reilly-Shah, MD, PhD, FASA, Professor of Anesthesiology & Pain Medicine, University of Washington | Seattle Children's Hospital

Regarding the recent PAAD related to ketorolac use in T&A: I am writing to express some concerns about the comparison between the two articles presented and, in particular, the validity of the study published by Shaikh et al. In short, the Shaikh article has significant statistical deficiencies in both the reporting and the conduct of the analysis. The rates of post-tonsillectomy hemorrhage are extremely low and well below the rates reported elsewhere in the literature, raising questions about the approach used by the authors to detect the outcome of interest. The rates of ketorolac administration are, in our view, suspiciously high based on what we know from other sources about the relative lack of uptake of ketorolac for T&A outside one or two hospital systems. Finally, the effect size reported by Shaikh et al is also suspiciously high, given previously published work in this area as well as our own findings. I have developed a detailed critique of the article expanding on each of these points which, unfortunately due to journal policy, will not be considered for publication as a letter to the editor. As such, I have published the critique on PubPeer: https://pubpeer.com/publications/6B44E9A2FD08A3E43BBD2466486EC8#1

The upshot here is that I do not believe it is fair to compare the two articles in an apples-to-apples manner, and based on our own findings as well as on the strength of previously published work in this area, we at Seattle Children's continue to have confidence in the safety of 0.5mg/kg ketorolac intraoperatively during tonsillectomy with or without adenoidectomy, given at the end of surgery and in consultation with the surgical team.

From Eshel A. Nir, MD, MSc, DESA

One safety issue that 'stuck-out' for me, while reading the Hansen et al paper, was the 'standardized' cart-top in Fig. 02. Albeit Seattle Children's 2017 Griggs paper is a trailblazer in that regard, small subtle changes - eg return to atropine 0.4mg vials (instead of prefilled syringes) deflate the concept of 'standardization'. It also is extremely precarious (as you noted on the March 16th PAAD) that look alike vials (light-blue-tops, like 0.4mg Atropine by AMERICAN REGENT, INC. and 0.5mg Dexmedetomidine by Orion-Pharma, both 1ml) may find themselves accidently on the same cart-top, instead of pre-filled bar-coded syringes. The late Dr. Litman (in his APSF cap...) was a true advocate for these, already in 2017 both research and editorial wise:

Lobaugh LMY, Martin LD, Schleelein LE, Tyler DC, Litman RS. Medication Errors in Pediatric Anesthesia: A Report From the Wake Up Safe Quality Improvement Initiative. Anesth Analg. 2017 Sep;125(3):936-942. doi: 10.1213/ANE.0000000000002279. PMID: 28742772.

Litman RS. How to prevent medication errors in the operating room? Take away the human factor. Br J Anaesth. 2018 Mar;120(3):438-440. doi: 10.1016/j.bja.2018.01.005. Epub 2018 Jan 27. PMID: 29452799.

Grigg EB, Litman RS. Feedback and constraints: rethinking medication safety countermeasures. Br J Anaesth. 2018 Dec;121(6):1188-1190. doi: 10.1016/j.bja.2018.08.003. Epub 2018 Sep 5. PMID: 30442240.

All said, the article is indeed an important Blueprint for any department wishing to make true the Primum edict!

From Anonymous

I read with interest the PAAD focusing on the Quality Improvement Report published in A and A, with a focus on Adaptx.  While I really respect and appreciate Dr. Martin and Dr. Low very much, I think it is really important to be clear about the commercial nature of the product they have put together and are expanding nationally.  The cost of using Adaptx (and joining the associated multicenter collaborations) is not insignificant.  I believe the product is good (we use it), and I applaud any effort to improve quality, but there is a mixing of commerce and academics here that needs to be clearly understood.  I appreciate that the PAAD noted the commercial nature of Adaptx, and the positions that Dr. Martin and Dr. Low hold in that company, but I feel some of the PAAD posting sounded almost as though this is the only option of its kind out there.  In fact, there are other options (such as MPOG and numerous data sharing/quality efforts going on through SPA) that are less expensive, traditional (non-commercial) in their structure. They  provide access to specific forms of quality data (and benchmarking) for participating institutions. Many have multiple quality improvement publications to their credit. While not as sophisticated as Adaptx, some of these organizations and their applications have become very innovative and quite flexible in the manner in which they can provide data.  

So, I am not trying to be critical, but I think the enthusiastic PAAD endorsement of Adaptx  (a commercial company marketed to help with quality improvement from an academic perspective) is one that needs to be carefully thought out and put into perspective.  Perhaps this is the direction we are going, but if it is, it should be done with very transparent appreciation of the implications and where we will end up