The Efficacy and Safety of Weighted Blankets to Reduce Agitation After Cardiac Catheterization and Electrophysiology Procedures in Pediatric Patients With Congenital Heart Disease.

OBJECTIVES

To assess the efficacy and safety of weighted blankets in reducing postprocedural agitation following cardiac catheterization and electrophysiology procedures.

DESIGN

Single-center, prospective, randomized clinical trial.

SETTING

Postprocedural recovery unit within a congenital heart center at a large academic tertiary care hospital.

PARTICIPANTS

Pediatric patients 3 to 17 years of age over a 2-year period.

INTERVENTIONS: Weighted blankets (compared with standard postprocedure management without weighted blankets).

MEASUREMENTS AND MAIN

RESULTS

The primary aim (to assess efficacy in reducing agitation) was measured using the Richmond Agitation-Sedation Scale (RASS) score and evaluating the number of sedative and pain medications given postprocedure. The secondary aim (safety related to weighted blanket use) was evaluated by examining trends in vital signs and adverse events. Of the 70 patients enrolled in the trial (31 with weighted blankets, 39 age-matched controls), there were no differences between groups in patient demographics, procedures performed, or intraprocedural anesthetic management. In addition, there were no differences between RASS scores or postprocedure sedative medication use between the two groups (primary efficacy aim). There were also no differences in vital sign parameters between groups, and no adverse events related to weighted blanket use (secondary safety aim).

CONCLUSIONS

Weighted blankets were not superior to standard postprocedural management in the early postprocedural period for patients with congenital heart disease after cardiac catheterization and electrophysiology procedures. But they were safe and may therefore be a reasonable, low-cost, nonpharmacologic option for some patients.