Infant sleep after immunization: randomized controlled trial of prophylactic acetaminophen

Abstract

Objective: To determine the effects of acetaminophen and axillary temperature responses on infant sleep duration after immunization.

Methods: We conducted a prospective, randomized controlled trial to compare the sleep of 70 infants monitored by using ankle actigraphy for 24 hours before and after their first immunization series at ∼2 months of age. Mothers of infants in the control group received standard care instructions from their infants' health care provider, and mothers of infants in the intervention group were provided with predosed acetaminophen and instructed to administer a dose 30 minutes before the scheduled immunization and every 4 hours thereafter, for a total of 5 doses. Infant age and birth weight and immunization factors, such as acetaminophen use and timing of administration, were evaluated for changes in infant sleep times after immunization.

Results: Sleep duration in the first 24 hours after immunization was increased, particularly for infants who received their immunizations after 1:30 pm and for those who experienced elevated temperatures in response to the vaccines. Infants who received acetaminophen at or after immunization had smaller increases in sleep duration than did infants who did not. However, acetaminophen use was not a significant predictor of sleep duration when other factors were controlled.

Conclusions: If further research confirms the relationship between time of day of vaccine administration, increased sleep duration after immunization, and antibody responses, then our findings suggest that afternoon immunizations should be recommended to facilitate increased sleep in the 24 hours after immunization, regardless of acetaminophen administration.

Trial registration: ClinicalTrials.gov NCT01321710.

Figures

FIGURE 1

Consolidated Standards of Reporting Trials (CONSORT) diagram of participant flow. T2 indicates the study visit 2 months after birth. a Actigraphic data were missing (mother declined), invalid (actigraphy error), or incomplete (<24 hours of continuous data immediately before and after immunization).

FIGURE 2

Changes in infants' 24-hour sleep quantities after immunization as a function of time of day of immunization.