Association between sugammadex and anaphylaxis in pediatric patients: A nested case-control study using a national inpatient database.

BACKGROUND

Sugammadex is used as a reversal drug during anesthesia. Although several case reports have described anaphylaxis following sugammadex infusion, little is known about the relationship between sugammadex and anaphylaxis, particularly in pediatric patients.

AIMS: The aim of this retrospective study was to investigate the association between sugammadex and in-hospital anaphylaxis in pediatric patients who underwent general anesthesia.

METHODS

We identified patients who underwent general anesthesia in a Japanese national inpatient database between July 2010 and March 2016. We conducted 1-4 case-control matching between patients with and without perioperative anaphylaxis. We calculated the adjusted odds ratio for sugammadex use and occurrence of anaphylaxis, using a conditional logistic regression analysis with adjustment for duration of anesthesia, antibiotics, and blood transfusions.

RESULTS

Among 835 405 patients who underwent general anesthesia, we identified 149 (0.018%) patients with anaphylactic shock and 472 (0.056%) with a combination of anaphylaxis associated signs/symptoms and skin lesions. Sugammadex use was not significantly associated with anaphylactic shock (odds ratio, 0.80; 95% confidence interval, 0.53-1.21; P = .29) or the combination of anaphylaxis associated signs/symptoms and skin lesions (odds ratio, 1.25; 95% confidence interval, 0.97-1.60; P = .08).

CONCLUSION

The present study showed no significant association between sugammadex and perioperative anaphylaxis in pediatric patients who underwent general anesthesia.