It’s a good thing that I’m writing this after all four double blind challenge (dosing) appointments are over (instead of after the second one), as I have more perspective, which will (hopefully) result in a less harrowing post. Let me first get this out of the way: the second oral challenge appointment (back on 11/9/11) was awful. It played out like the host of nightmares I had imagined might occur, and it took us a bit to recover from it, which is why I didn’t write up our experience right away. Each boy was given their mystery nut that day, and Ari’s process moved forward as all of his challenges did – smoothly, with clear indicia of his reactions that gave the Stanford staff the information they needed in a timely and calm manner, and resulted in the challenges ending for him prior to a strong reaction. The staff only needs to see a small reaction at each challenge - they don’t need it to be, nor do they want, a massive reaction – and for Ari, that presented as swollen lips (the little indentation area in the middle of the top lip that Aviv has named ‘plupit’), redness at the edges of his mouth, and what he describes as a ‘spicy’ feeling in his mouth with evidence of some hives there. The oral challenge process for Ari mirrored Ari’s personality: predictable, calm and exact in communication (with no shades of grey or confusion). With Ari, what you see is what you get.
Aviv is a different story, both in personality, and through this process. He has been described as many medical professionals as ‘complex’ and hard to interpret. When he had his strong reaction during the first challenge day (getting very angry, welty and yelling about the spicy feeling in his mouth), we were surprised that the reaction was so strong, so fast. It turns out that we all missed the first symptom of his reaction (and missed it again during his second challenge), as it’s unusual; having seen it occur twice, however, it’s very clear to us all now that the way the first symptom of a reaction presents for Aviv is not in his mouth but in his ears. He complained of ear pain after the second dose on both the first and second challenge days, and both times, we thought his ear pain was due to the headphones he was wearing to watch a movie. (The oral challenge days are long ones in the hospital, and to keep the kids occupied, we bring an iPad loaded with movies for them.) The staff checked him after he complained of the ear pain both times, but didn’t see anything unusual – no redness, welts, spike in blood pressure, etc. Whether the pain was actually in his ears, or in the throat/adenoidal area (that is best explained by a 4 year old as ear pain), we don’t know. What we do know (now) is that we all missed that first symptom, and as a result, kept going with the dosing. Thus, instead of Aviv stopping the increased dose of the mystery nut when he first started to react (and giving him meds to stop the reaction), he was given the next dose of nuts. What happened then is that he freaked out – screaming, kicking, dots starting to form on his skin, you name it. It was clear that the dosing was over for the day, and it was time for him to take the antihistamines to stop the reaction. He didn’t like the one offered, and in trying to help him feel a bit of control (as he is a kid that gets very upset when he feels he has no control), we gave him the choice of which medication to take at that moment. Huge mistake. Every second mattered, and as we tried to convince him to take the meds, his reaction increased exponentially. What we learned that day is it takes 6 minutes for Aviv to go from zero to sixty, meaning to go from ingestion to full blown, covered in welts from head to toe, hampered breathing, reaction. I sat in the hospital bed holding Aviv to me (as he was writhing and lashing out), trying to apply antihistamine cream to his entire body while the staff forced medication into him orally and via an oxygen and albuterol mask. We were behind the proverbial 8 ball, and it was not good. It took many hours and the legal maximum of medication (literally, the staff calculated and administered the max amounts Aviv could have, based on weight) to bring him back. In what I could describe as either an aloof personality or having an amazing survival/defense mechanism, Ari seemed oblivious to all of the commotion occurring around him. While the staff (and Orr & I) went into high gear to take care of Aviv, rolling over an oxygen tank, monitoring equipment, etc., Ari – who was laying in the same hospital bed with Aviv and I! – sat fixated on the movie he was watching, headphones on, and didn’t notice a thing.
We went home exhausted that night, all crawled into bed and fell asleep together. The next morning, both boys popped up like nothing had occurred and neither seemed to remember what had gone on; it was only Orr and I that seemed scarred, and we soon had to shake it off, because there had been an appointment cancellation in the study, which enabled us to take the boys back for their third oral challenge day. As rough as the first two had been, the goal was to get through these four oral challenges, so that we could move to the treatment phase of the trial. Luckily, with our new found knowledge of Aviv’s surprise ‘ear pain’ symptom, the next two challenges went MUCH smoother; identifying the reaction as soon as it starts enables you to stop it quickly, without moving to the painful or dangerous stages. Additionally, one of those was Aviv’s placebo day, so he didn’t react at all.
At the end of the fourth challenge (12/5/11), they ‘unblinded’ the results so that we knew which nut was administered on which day. The most interesting part was that Ari’s first challenge day – that we thought might be a placebo, but weren’t sure – wasn’t. That meant that there was an inconclusive reaction to the nut (walnut) in this setting, which was at odds with his skin tests, blood tests, and his first live reaction several years ago. Dr. Nadeau suggested we try an open challenge to it – which means going through the same oral challenge protocol in the hospital, but with the knowledge that it’s walnut – to see what occurs. We did that yesterday, and observed Ari’s reaction to it. With that final piece of information in, Dr. Nadeau decided on the three nuts that each boy will be treated for, and shared with us the fantastic news that each of her 5 allergy trials has now been approved by both the FDA and the Stanford IRB, so they’re all open and moving forward! All pre-treatment work having been finished, Ari and Aviv will begin actual treatment in January. The best holiday present ever!
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