Remembering the classics: Should children drink before discharge from day surgery?
Mark S. Schreiner MD
The only constant in the practice of medicine is change. Sometimes change in clinical practice is glacial and because it is so slow may be difficult to see and appreciate. At other times, it is meteoric and change occurs in almost a heartbeat. In keeping with Ron Litman’s vision, I try to provide a “remembering the classics” article on a regular basis to the PAAD readership by one of the authors who performed a classic “game changing” study. Over the past 2 years, I’ve asked some of the pioneers in pediatric anesthesia to remind us of their discoveries with an emphasis on why and how they decided to perform a clinical trial and what obstacles they had to overcome while performing them. In today’s PAAD, I’ve asked Dr. Mark Schreiner to pick articles that he and his colleagues at the Children’s Hospital of Philadelphia (CHOP) performed in the past century (OK that’s a bit harsh for studies performed in the 1990s) that would be of interest to our readers. Myron Yaster MD
Original articles
Schreiner MS, Nicolson SC, Martin T, Whitney L Should children drink before discharge from day surgery? Anesthesiology. 1992 Apr;76(4):528-33. doi: 10.1097/00000542-199204000-00007.PMID: 1550277
Weinstein MS, Nicolson SC, Schreiner MS. A single dose of morphine sulfate increases the incidence of vomiting after outpatient inguinal surgery in children. Anesthesiology. 1994 Sep;81(3):572-7. doi: 10.1097/00000542-199409000-00008. PMID: 8092501
Myron has asked me to choose and reflect back on a study I conducted and wrote up years ago. I have chosen two papers that both taught me lessons in dealing with journal editors.
In the late 1980s and early 1990s my office was located across the hall from the day surgical pre-discharge unit (DSU). As I would walk down the hall to the bathroom or to lunch, I couldn’t help but notice how many children vomited in the hallway on their way to the garage. At the time, we required all patients to demonstrate an ability to drink clear liquids before discharge home. If a child was still in the unit as the day neared a close and they still hadn’t had anything to drink, they were usually given extra iv fluids and sent home anyway.
As a pediatrician, I was trained to treat children presenting to the ED with nausea and vomiting by having the parents fast their child for one or two hours. It struck me that we were forcing nauseated children to drink instead of fasting them until they felt ready.
This led to a clinical trial where we randomized day surgical patients to either a mandatory drinking group or an elective drinking group.(1) The latter were offered liquids but not required to drink. To ensure that the nursing staff could keep things consistent and to avoid parental confusion, we randomized by the week – everyone was treated the same for the entire week. About 20% of the elective drinkers chose not to drink. They had a lower incidence of vomiting in the DSU (14%) vs 23% for the mandatory drinkers. At home, the incidence was virtually identical and overall, there was a 7% difference. As a result, the Children’s Hospital of Philadelphia revised its policies and eliminated the requirement for drinking prior to discharge.
In my mind, this was a simple clinical trial designed to answer a single question. However, at least one journal reviewer was fixated on the role of opioids and other factors on post-operative vomiting. The paper went back and forth many times over a period of approximately 9 months until finally, I prevailed in convincing the editor that these were questions that our study wasn’t designed to address.
Given the interest in the role of opioids in post-operative vomiting, I then designed a study to address that issue.(2) We randomized children undergoing inguinal hernia repair with a nerve block to receive either morphine 0.1 mg/kg or placebo. In the PACU, children whose behavior suggested post-op pain received ketorolac. Only 20% of those in the morphine group received ketorolac compared to 63% in the placebo group. Those randomized to morphine were also calmer, sleepier and less agitated in the PACU early on, but by discharge the groups were indistinguishable. The incidence of vomiting over the first 24 hours was higher in those receiving morphine (56%) vs those in the placebo group (25%).
Thinking I had addressed the concerns raised by my prior study, I blithely submitted the paper to Anesthesiology. This time, the objections were quite different. One reviewer opined that my paper added “nothing new about the pharmacokinetics or pharmacodynamics of morphine in children” and recommended rejection. This time I had to revisit the review process of my prior paper with the editor. I pointed out that that paper had been held up for 9 months because the reviewer wanted us to elucidate the role of opioids in post-op vomiting. This time, the editor pretty quickly came around to our point of view and the paper was accepted despite the negative review of an associate editor.
I learned a number of lessons that helped me in my approach to subsequent journal reviews. Don’t assume that the reviewer(s) know as much about the conduct of clinical trials as you do; a trial that randomizes children to one of two interventions probably can’t address other issues that weren’t included as part of the trial planning process. Try to address the reviewers concerns as completely as possible but be prepared to fight back when the changes, revisions or additional analyses requested don’t make sense. Lastly, if you believe what you’ve done is important, don’t accept disparaging comments that reflect reviewer bias; push back.
References
1. Schreiner MS, Nicolson SC, Martin T, Whitney L. Should children drink before discharge from day surgery? Anesthesiology 1992;76:528-33.
2. Weinstein MS, Nicolson SC, Schreiner MS. A single dose of morphine sulfate increases the incidence of vomiting after outpatient inguinal surgery in children. Anesthesiology 1994;81:572-7.