Effect of liposomal lidocaine and sucrose alone and in combination for venipuncture pain in newborns.

OBJECTIVE: To determine the relative effectiveness of liposomal lidocaine, sucrose, and their combination for reducing pain in term newborns. METHODS: Ours was a double-blind, randomized, controlled, double-dummy trial of 330 healthy term newborns. Before venipuncture for the newborn screening test, neonates received (1) 1 g of liposomal lidocaine cream topically, (2) 2 mL of 24% sucrose solution orally, or (3) sucrose and liposomal lidocaine. The facial grimacing score (0-100) was used to assess pain. Adverse events and lidocaine levels were used to assess safety. RESULTS: Infant characteristics did not differ among groups. Facial grimacing scores were lower in the sucrose group compared with those in the liposomal lidocaine group (mean difference: -27 [95% confidence interval (CI): -36 to -19; P < .001) and for the sucrose plus liposomal lidocaine group compared with those in the liposomal lidocaine group (mean difference: -23 [95% CI: -31 to -14]; P < .001). The sucrose and sucrose plus liposomal lidocaine groups did not differ (mean difference: -5 [95% CI: -13 to 4]; P = .3). Local skin reactions were not observed, and the incidence of spitting up did not differ between sucrose-exposed and non-sucrose-exposed infants (1.4% vs 2.7%, respectively; P = .22). The mean (SD) plasma lidocaine level was 44.6 (55.3) ng/mL. CONCLUSIONS: Sucrose was more effective than liposomal lidocaine for reducing pain during venipuncture in newborns. The addition of liposomal lidocaine to sucrose did not confer any additional benefit to sucrose alone. There was no evidence of harm from liposomal lidocaine or sucrose.

Practices and perceptions regarding pain and pain management during routine childhood immunizations: Findings from a focus-group study with nurses working at Toronto Public Health, Ontario.

INTRODUCTION: Despite the availability of a variety of evidence-based interventions, it has previously been reported that the majority of infants and children undergo vaccine injections without the benefit of analgesia. Nurses in public health administer a substantial number of injections; however, their attitudes and practices surrounding acute pain during vaccine injections have not been previously explored. METHODS: A focus-group interview was conducted in Toronto, Ontario, with 10 nurses who immunize children. Participants reported their perceptions and practices with regard to vaccine injection pain and pain management. RESULTS: THREE KEY THEMES EMERGED: environmental and process factors, perceptions regarding the effectiveness of different analgesic interventions, and perceptions regarding pain and fear. Participants reported a lack of control over their environment, resulting in fear and discomfort for children. They recommended increased support from external partners such as school teachers and administrators. Participants reported that pharmacological interventions, such as topical local anesthetics, were not used; however, psychological and physical interventions were commonly used. Nurses questioned the effectiveness of topical anesthetics, and indicated that more education was required regarding effective analgesic interventions. Needle pain was reported to be the most prominent concern for children undergoing vaccine injections, and children were described as being fearful. DISCUSSION: Nurses reported vaccination setting, analgesic effectiveness and relative importance given to pain as important factors for pain and pain management during vaccine injections. Future studies should explore whether additional perspectives are present in vaccinators in other geographical regions. The effectiveness of educational resources and pain management programs aimed at improving current practices should be investigated.

A randomized controlled trial of analgesia during vaccination in adults.

Although immunization injections are the most common painful medical procedures, pain-relieving interventions are not routinely used. In this randomized controlled trial, we compared the effectiveness of topical anesthesia using liposomal lidocaine to: (1) vapocoolant spray using a proprietary blend of 1,1,1,3,3-pentafluoropropane and 1,1,1,2-tetrafluoroethane; (2) nurse-administered tactile stimulation; or (3) self-directed distraction by means of reading a magazine. Liposomal lidocaine was more effective (p

A systematic review of measures for reducing injection pain during adult immunization.

OBJECTIVE: To evaluate the effectiveness of different pain-relieving interventions to reduce pain from immunization in adults. DATA SOURCES: MEDLINE (1950 to October Week 3 2008) PsycINFO (1967 to December Week 1 2008), CINAHL (1982 to October Week 4 2008), EMBASE (1980 to 2008 Week 43) and the Cochrane Central Register of Controlled Trials (3rd Quarter 2008). REVIEW METHODS: Databases were searched for trials of pharmacological, behavioural, physical or operator-dependant techniques to reduce pain from immunization in adults. The primary outcome was pain as assessed by visual analogue scale or other numeric rating scale. RESULTS: Six studies representing 853 participants were identified. One study evaluating pharmacological interventions (lidocaine-prilocaine) found them to be effective in reducing pain from immunization. Similarly, two studies evaluating physical pain relieving techniques, either skin cooling interventions (Fluori-Methane) or tactile stimulation (manual pressure at the site of injection) found them to reduce pain. One study of jet injectors found them to be more painful than conventional needle and syringe. Neither freezing needles nor warming vaccines was found to be effective in reducing pain. No studies investigated psychological interventions or oral analgesics (acetaminophen and ibuprofen). CONCLUSION: There was limited evidence to support the use of lidocaine-prilocaine, Fluori-Methane and manual pressure for reducing immunization pain in adults. There was limited evidence of more pain with jet injectors compared to needle and syringe. Due to limited data, we recommend further investigation of methods to reduce immunization pain in adults, primarily psychological and physical techniques.

Physical interventions and injection techniques for reducing injection pain during routine childhood immunizations: systematic review of randomized controlled trials and quasi-randomized controlled trials.

BACKGROUND: Vaccine injections are the most common reason for iatrogenic pain in childhood. With the steadily increasing number of recommended vaccinations, there has been a concomitant increase in concern regarding the adequacy of pain management. Physical interventions and injection techniques that minimize pain during vaccine injection offer an advantage over other techniques because they can be easily incorporated into clinical practice without added cost or time. Their effectiveness, however, has not previously been studied using a systematic approach. OBJECTIVE: The purpose of this review was to determine the effectiveness of physical interventions and injection techniques for reducing pain during vaccine injection in children. METHODS: MEDLINE, EMBASE, CINAHL, and the Cochrane Central Register of Controlled Trials databases were searched to identify randomized controlled trials (RCTs) and quasi-RCTs that determined the effect of physical interventions and injection techniques on pain during injection of vaccines in children 0 to 18 years of age, using validated child self-reported pain or assessments of child distress or pain made by others (parent, nurse, physician, observer). We sought to determine the effects of: (1) different formulations of the same vaccine; (2) position of the child during injection; (3) intramuscular versus subcutaneous injection; (4) cooling of the skin at the injection site with ice before injection; (5) stroking the skin or applying pressure close to the injection site before and during injection; (6) order of vaccine injection when 2 vaccines were administered sequentially; (7) simultaneous versus sequential injection of 2 vaccines; (8) vaccine temperature; (9) aspiration before injection; (10) anatomic location of injection; (11) aspects of the needle (gauge, length, angle of insertion, speed of injection); and (12) combinations of these interventions. All meta-analyses were performed using a fixed-effects model. RESULTS: Nineteen RCTs involving 2814 infants and children (0-18 years of age) were included in the systematic review. One study included children >or=16 years and adults (n = 150). Interventions with positive findings are summarized here. In 2 trials that used child self-reports of pain during administration of measles-mumps-rubella vaccine (total, 680 children with complete data), the Priorix vaccine caused less pain than the M-M-R(II) vaccine (standardized mean difference [SMD], -0.66; 95% CI, -0.81 to -0.50; P < 0.001). In 3 trials (404 children), the number needed to treat (NNT) with Priorix to prevent 1 child from crying was 3.2 (95% CI, 2.6-4.2). In 4 trials (281 infants and children), sitting children up or having parents hold infants appeared to cause less pain than the supine position, but the difference was not statistically significant; however, significant heterogeneity was found among the studies, and a qualitative approach was used for data analysis. A benefit was observed for 3 of the 4 studies; the SMD ranged from -0.4 to -0.8 (P < 0.05 for all analyses). The negative findings observed for the remaining study may have been the result of methodologic heterogeneity. Stroking the skin close to the injection site before and during injection reduced pain in 1 trial (66 children; SMD, -0.53; P = 0.03). One study (120 children) found that when diphtheria-polio-tetanus-acellular pertussis-Haemophilus influenzae type b (DPTaP-Hib; Pentacel) and pneumococcus (Prevnar) were injected sequentially during the same office visit, observer- and parent-reported pain scores were lower when DPTaP-Hib was injected first (SMD, -0.40 and -0.57, respectively; P