Among children receiving intramuscular and subcutaneous injection of vaccines, does application of topical anesthetics on the skin before the injection reduce pain at the time of injection?
Background and evidence Topical anesthetics reduce pain associated with needle procedures, including venipuncture and intravenous cannulation.57 Our systematic review12 included 10 trials that evaluated the effects of topical anesthetics in a total of 1156 infants and children (up to 15 years of age).17,58–66 Of the seven studies that compared topical anesthetics with placebo cream or patch, six showed that these drugs were effective in reducing pain.58–63 In the negative study,64 older children (11–15 years) were enrolled. In addition, there were certain methodologic limitations that might explain the results, including use of an insensitive pain assessment method and rating of pain performed with the help of the physician. In two trials that included a no-treatment (control) group,65,66 topical anesthetics were ineffective, and in another trial, they were effective.17 Again, these results might be explained by some methodologic limitations, including lack of blinding and nurses’ interactions with the no-treatment (control) group, which equalized responses between the groups; increased anticipatory anxiety because of a one-hour application time; and close proximity of peers (children from the same classroom) influencing self-reported pain ratings. We concluded that topical anesthetics are effective for reducing vaccination pain. We found no evidence of interference with vaccine immunogenicity for measles–mumps–rubella vaccine or the vaccines for diphtheria, tetanus, acellular pertussis, poliovirus, Hemophilus influenzae type B and hepatitis B.59–61
Recommendation To reduce pain at the time of injection, encourage parents to use topical anesthetics during vaccination of children (grade A recommendation, based on level I evidence).
Clinical considerations Topical anesthetics are available without a prescription. Topical anesthetics currently available for sale in Canada are lidocaine–prilocaine 5% cream or patch (EMLA, AstraZeneca Canada), amethocaine 4% gel (Ametop, Smith and Nephew) and liposomal lidocaine 4% cream (Maxilene, RGR Pharma).
Education of parents (written, electronic or in person) is required, including specifying the exact site or sites of administration. Topical anesthetics must be applied ahead of time, 20–60 minutes before the injection, depending on the commercial product being applied. The topical anesthetic can be applied upon arrival at the clinic or school (by a parent or a qualified health care professional or delegate) or before departure from home. If multiple vaccines are being injected during the same visit, the topical anesthetic can be applied at two separate sites (e.g., right and left legs). The vaccine or vaccines must be injected where the anesthetic has been applied. Health care providers can use a nontoxic marker to outline the area of application. The cost per dose is $5–$10.
Cream or gel preparations must be covered with a dressing so that they are not accidentally wiped off the skin or ingested. One approach is to apply the medication directly on the sticky side of the dressing, flip the dressing over and then attach it to the body location where the injection is planned, firmly pressing the edges so that the cream does not leak out. When removing the dressing, stretch it out and then lift it, instead of just pulling it off. Pulling off a dressing is like pulling off an adhesive bandage and may cause some discomfort to the child.
Previous studies have shown that parents are willing to accommodate the administration of topical anesthetics into their schedules, are willing to pay to reduce vaccination pain and are able to apply topical anesthetics to their children’s skin before needle procedures if instructed on how to do so.7,8,62,67,68
Transient changes in skin colour and sensation are common with the use of topical anesthetics, occurring in up to one-third to one-half of individuals. Monitor the skin for allergic reactions. Topical anesthetics are considered safe for children of all ages. However, administration of excessive doses and/or prolonged application times can lead to serious adverse effects, including irregular heartbeat, seizures and difficulty breathing (see Health Canada advisory www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2009/emla_ametop_pc-cp-eng.php).
In the event that the analgesic is ineffective, clinicians and parents should consider anxiety and genetic variability as possible contributory factors.69
Although there is no evidence of interference with vaccine immunogenicity, additional studies are recommended to rule out an interaction between topical anesthetics and all of the common childhood vaccines.
https://scholar.google.com/scholar_lookup?journal=J+Pediatr&title=Use+of+lidocaine–prilocaine+cream+for+vaccination+pain+in+infants&author=A+Taddio&author=I+Nulman&author=M+Goldbach&volume=124&publication_year=1994&pages=643-8&pmid=8151485&#d=gs_qabs&t=1662414761757&u=%23p%3DDh2bdWqBgKwJ
Pretreatment with EMLA decreases infant pain from DPT vaccinations. Application of these data is limited to healthy infants receiving DPT vaccinations.
Conclusion.
Parent application of EMLA appears to be as effective as clinician application in reducing children's pain and distress associated with IV insertion. Permitting parents to apply the EMLA at home can allow children who are having procedures on an outpatient basis to benefit from topical anesthesia without having to arrive early to the clinic or hospital. Additionally, application by parents may result in less anticipatory anxiety for younger children.