A randomized trial of rotavirus vaccine versus sucrose solution for vaccine injection pain.

OBJECTIVE: Sucrose solutions are analgesic in infants. Oral rotavirus vaccine contains sucrose, however, it is not known if it possesses analgesic properties. The objective was to compare the analgesic effectiveness of rotavirus vaccine to sucrose solution when administered prior to injectable vaccines. METHODS: Infants 2-4 months of age receiving oral rotavirus vaccine and two separate injectable vaccines on the same day were randomized to rotavirus vaccine (Rotarix) first followed by the injectable vaccines and sucrose (Tootsweet) afterwards, or vice versa. Pain was assessed by blinded raters using the Numerical Rating Scale (NRS, range 0-10) (parents, clinicians), or Modified Behavioural Pain Scale (MBPS, range 0-10) and cry duration (observers). Data were analyzed using t-tests or χ(2)-tests; Bonferroni correction was applied to correct for multiple comparisons, as appropriate. RESULTS: Altogether, 120 infants participated: 60 were randomized to rotavirus vaccine first. Groups did not differ in demographics, including; age (p=0.448) and sex (p=0.464). The mean pain score (standard deviation) for both vaccine injections did not differ between infants given rotavirus vaccine first versus sucrose solution first: observer MBPS, parent NRS and clinician NRS scores were 7.4 (1.6) vs. 7.7 (1.6), 4.9 (2.1) vs. 5.8 (2.1), and 4.2 (2.1) vs. 4.6 (2.2), respectively. Similarly, there was no difference between groups in cry duration. CONCLUSION: Rotavirus vaccine did not differ from sucrose solution in reducing injection-induced pain. Based on the findings, it is recommended that rotavirus vaccine be administered prior to injectable vaccines in infants aged 2 and 4 months.

Impact of prenatal education on maternal utilization of analgesic interventions at future infant vaccinations: a cluster randomized trial.

Analgesic interventions are not routinely used during vaccine injections in infants. Parents report a desire to mitigate injection pain, but lack the knowledge about how to do so. The objective of this cluster-randomized trial was to evaluate the effect of a parent-directed prenatal education teaching module about vaccination pain management on analgesic utilization at future infant vaccinations. Expectant mothers enrolled in prenatal classes at Mount Sinai Hospital in Toronto were randomized to a 20-30minute interactive presentation about vaccination pain management (experimental group) or general vaccination information (control group). Both presentations included a PowerPoint (Microsoft Corporation, Redmond, WA, USA) and video presentation, take-home pamphlet, and "Question and Answer" period. The primary outcome was self-reported utilization of breastfeeding, sugar water, or topical anaesthetics at routine 2-month infant vaccinations. Between October 2012 and July 2013, 197 expectant mothers from 28 prenatal classes participated; follow-up was obtained in 174 (88%). Maternal characteristics did not differ (P>0.05) between groups. Utilization of one or more prespecified pain interventions occurred in 34% of participants in the experimental group, compared to 17% in the control group (P=0.01). Inclusion of a pain management module in prenatal classes led to increased utilization of evidence-based pain management interventions by parents at the 2-month infant vaccination appointment. Educating parents offers a novel and effective way of improving the quality of pain care delivered to infants during vaccination. Additional research is needed to determine if utilization can be bolstered further using techniques such as postnatal hospital reinforcement, reminder cards, and clinician education.

A randomized controlled trial of clinician-led tactile stimulation to reduce pain during vaccination in infants.

BACKGROUND: Clinician-led tactile stimulation (rubbing the skin adjacent to the injection site or applying pressure) has been demonstrated to reduce pain in children and adults undergoing vaccination. OBJECTIVE: To evaluate the analgesic effectiveness of clinician-led tactile stimulation in infants undergoing vaccination. METHODS: This was a partially blinded randomized controlled trial that included infants undergoing vaccination in a private clinic in Toronto. Infants were randomly allocated to tactile stimulation or no tactile stimulation immediately prior to, during, and after vaccination. The primary outcome was infant pain, assessed using a validated observational measure, the Modified Behavioral Pain Scale (MBPS; range = 0-10). RESULTS: Altogether, 121 infants participated (n = 62 tactile stimulation; n = 59 control); demographics did not differ (P > .05) between groups. MBPS scores did not differ between groups: mean = 7.2 (standard deviation = 2.4) versus 7.6 (1.9); P = .245. CONCLUSION: Tactile stimulation cannot be recommended as a strategy to reduce vaccination pain in infants because of insufficient evidence of a benefit.

Teaching parents to manage pain during infant immunizations: laying the foundation for better pain management practices.

OBJECTIVE: To evaluate knowledge uptake from a parent-directed factsheet about managing pain during infant vaccinations, and the added influence of a pretest. MATERIALS AND METHODS: Solomon 4-group randomized controlled trial. New mothers hospitalized after the birth of an infant were randomized to 1 of 4 groups: 2 included the intervention (factsheet about pain management) and 2 included the control (information on another topic). A pretest was given to 1 intervention and 1 control group. Following maternal review of allocated information, posttests were administered in all groups. Both control groups received the information after posttesting. A follow-up telephone survey after 2 months measured knowledge retention and utilization of pain management interventions. RESULTS: A total of 120 mothers participated (July, 2012 to February, 2013); demographics did not differ among groups. The 2 factsheet groups demonstrated more knowledge (P<0.05) about effective pain management (mean without pretest: 5.6 [SD=2.0]; with pretest: 6.9 [1.6]) compared with the 2 control groups (without pretest: 3.2 [2.2]; with pretest: 3.4 [2.5]) immediately after review; and the factsheet and pretest group scored higher than the factsheet only group. In groups with a prefactsheet baseline knowledge test, knowledge was higher at follow-up compared with baseline. Follow-up knowledge and utilization of pain management interventions did not differ among groups. CONCLUSIONS: The factsheet led to acute gains in knowledge and knowledge gains persisted after 2 months. Acutely, knowledge was bolstered by the pretest. These results can be used to guide future research and implementation of the factsheet.