Oxycodone vs Placebo in Children with Undifferentiated Abdominal Pain

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Kokki H, Lintula H, Vanamo K, Heiskanen M, Eskelinen M. Arch Pediatr Adolesc Med 2005;159:320-325

Context Analgesics for children with acute abdominal pain are often withheld for fear that they might mask physical examination findings and thus might be unsafe. This viewpoint has been challenged recently.

Objectives To evaluate the effects of buccal oxycodone on pain relief, physical examination findings, diagnostic accuracy, and final clinical outcomes in children with acute abdominal pain.

Design Prospective, randomized, double-blind, and placebo-controlled trial between December 2001 and November 2003.

Setting University teaching hospital in Finland.

Participants A total of 104 children 4 to 15 years of age with abdominal pain <7 days' duration were screened, and 63 children with pain scores of 5 or higher on a 10-cm visual analog scale were eligible for the trial.

Interventions Children were randomized to receive buccally either 0.1 mg/kg of oxycodone hydrochloride (n=32) or the same volume of normal saline (n=31). The same surgeon described the physical findings and indicated a provisional diagnosis and a provisional disposition before the children received the study medication and at 1 hour and 3.5 hours after initial dosing. Pain scores were recorded at baseline and every 30 minutes for 3.5 hours after the first study drug administration.

Main Outcome Measures Pain intensity difference, presence or absence of abdominal guarding, and diagnostic accuracy.

Results The demographic characteristics, initial pain scores, and physical signs and symptoms were similar between the two groups. Both study drugs were associated with decreasing pain scores. The summed pain intensity difference over 7 observations was significantly greater in the oxycodone group, 22 ± 18 cm, than in the placebo group, 9 ± 12 cm (mean difference 13 cm, with a 95% confidence interval of 2-24 cm; P=.04). The diagnostic accuracy increased from 72% to 88% in the oxycodone group and remained at 84% in the placebo group after study drug administration. Laparotomy was performed in 17 patients in the oxycodone group and in 14 patients in the placebo group. Four patients without appendicitis underwent exploratory laparotomy in each group. One patient in the placebo group was initially diagnosed as having nonspecific abdominal pain, but at 14 hours, she was operated on for appendiceal perforation.

Conclusions Early administration of buccal oxycodone provides a significant pain relief to children with acute abdominal pain, without adversely altering the clinical signs or obscuring the surgical diagnosis.

Comment Most physicians have been taught to withhold pain medication in patients with acute abdominal pain for fear that it may mask worsening symptoms and lead to an adverse clinical outcome. This concern has not been borne out in recent studies with adult patients. Kokki and colleagues have conducted a well-designed, valid, randomized study of buccal oxycodone in children. Both saline placebo and oxycodone resulted in a reduction in pain intensity. The study was powered to detect a difference in the main outcome measure: the summed pain intensity difference (SPID). The SPID is the total of each of the differences in pain ratings from baseline to a specific point in time (every 30 minutes from administration to 3.5 hours later). There was a statistically significant difference in the SPID between the two groups, but this difference was clinically small.¹ Although not adequately powered to look at the potential to miss important adverse outcomes, the study did not find any increased adverse outcomes among those children who were given oxycodone. In fact, the ability to perform a more accurate examination (specifically examining for the presence of guarding) seemed to improve after the analgesic. If that result holds true in larger studies, this could have important implications for children. Finally, as the authors note, one other limitation of the present study is that a surgeon evaluated all children before the study medication was administered. This makes it difficult to generalize these results to children who are initially presenting to an emergency department and who have not yet had a surgical evaluation—another study looking at this group of children would be welcome.

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1. Bowen M, Poehling KA, Gunn VL, Carroll KN, Callahan ST, Arbogast PG, et al. Does the use of oxycodone affect diagnostic accuracy in children with acute abdominal pain?. Arch Pediatr Adolesc Med. 2005;159:326–328
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