Background: Infants experience undue pain with multiple immunization injections.
Objective: To assess the effectiveness, feasibility, and parental acceptance of a simple combination pain reduction intervention for infants receiving multiple immunization injections.
Design: Randomized, controlled, clinical trial.
Setting: Academic hospital-based primary care center.
Participants: Infants receiving their 2-month immunizations, consisting of 4 injections (diphtheria and tetanus toxoids and acellular pertussis vaccine, inactivated poliovirus vaccine, Haemophilus influenzae b conjugate and hepatitis B vaccine [Comvax], and heptavalent pneumococcal conjugate vaccine [Prevnar]).
Interventions: Subjects were randomly assigned to the intervention or control group for administration of 4 injections. The intervention group received sucrose and oral tactile stimulation (with a pacifier or a bottle) and were held by their parents during immunization. The control group did not receive these interventions (standard practice).
Main outcome measures: Blinded assessment of audiotaped crying, heart rate, parent preference for future use of the injection technique, and nurse-rated ease of vaccine administration.
Results: One hundred sixteen infants (mean +/- SD age, 9.5 +/- 2.0 weeks) participated. The median (25th-75th percentile range) first cry duration was 19.0 (5.8-62.8) seconds for the intervention group compared with 57.5 (31.0-81.5) seconds for the control group (P =.002). Parents of the intervention group reported a stronger preference for future use of the injection procedure. For intervention vs control, the median (25th-75th percentile) parent preference visual analog scale score was 97.0 (82.0-100.0) vs 44.0 (5.0-77.2) (P<.001) (100 indicates definitely prefer). Nurse-rated ease of vaccine administration was equivalent for both treatment groups.
Conclusions: Combining sucrose, oral tactile stimulation, and parental holding was associated with significantly reduced crying in infants receiving multiple immunization injections. Parents stated a strong preference for future use of this method, and nurses found the intervention injection technique easy to apply.