Acta paediatrica
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Randomized Controlled Trial Comparative Study Clinical Trial
Oral versus rectal midazolam as a pre-anaesthetic sedative in children receiving dental treatment under general anaesthesia.
Dental treatment in children who are too young or too apprehensive to cooperate is often performed under sedation. In Sweden, the tradition has been to administer sedatives rectally in small children, but oral liquid sedation is now increasingly used. ⋯ Both the oral and the rectal routes can in most cases be appropriate. However, the better sedative effect of rectal administration of midazolam makes it a more favourable route in pre-cooperative and non-compliant children.
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Randomized Controlled Trial Multicenter Study Clinical Trial
A randomized double-blind, placebo-controlled trial of the EMLA patch for the reduction of pain associated with intramuscular injection in four to six-year-old children.
The effectiveness of a eutectic mixture lidocaine-prilocaine topical anaesthetic cream (EMLA) patch compared with a placebo patch in the reduction of pain associated with intramuscular immunization was evaluated. As part of the study, 161 children (aged 4-6-y) undergoing routine diphtheria, pertussis, tetanus and polio (DPTP) immunization in five urban and five rural private office settings were randomly assigned to an EMLA patch (n = 83) or a placebo patch control group (n = 78). Pain measurements included: child's self-report on a Faces Pain Scale; facial action on the Child Facial Coding System; the Children's Hospital of Eastern Ontario Pain Scale and parent and technician ratings on a Visual Analogue Scale. Parents also rated their own and their child's immunization-related anxiety on a Visual Analogue Scale. The EMLA patch group had significantly less pain on all four pain measures compared with the placebo group. Of the children in the placebo group, 43% had clinically significant pain, compared with 17% of children in the EMLA patch group. No severe adverse symptoms occurred as a result of either EMLA or placebo patch application. ⋯ The EMLA patch reduced immunization pain in 4 to 6-y-old children during needle injection.
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Randomized Controlled Trial Comparative Study Clinical Trial
Comparison of EMLA cream versus placebo in children receiving distraction therapy for venepuncture.
Eutectic mixture of local anaesthetics (EMLA) cream is used routinely as a local anaesthetic prior to venepuncture in children. Despite this, however, a significant proportion of children will still be distressed. Cognitive-behavioural interventions, such as distraction by breathing and blowing exercises, have been used and found to be helpful as alternative coping strategies. There is, however, a paucity of data regarding effectiveness. We have evaluated the efficacy of distraction therapy as a coping strategy before and during venepuncture, and in these children evaluated the need for EMLA using a prospective, randomized, double-blind, placebo-controlled clinical trial. Twenty-eight children attending for venepuncture were recruited, median age 6 y (range 4-8 y), and randomly allocated to receive either EMLA or a placebo cream. All were given distraction therapy prior to and during the procedure by a play specialist. Venepuncture was carried out by one investigator. A modified paediatric pain assessment chart was used for objective pain score at the end of the procedure. After one exclusion, the treatment group (17 children) and the placebo group (10 children) were similar: median age of 6 and 7 y (range 4-8), median baseline and post-procedure heart rate and oxygen saturation. The median (interquartile range) for total pain score in the treatment group was 1 (0 to 4.5) and in the control group 1 (0 to 2.3). There was no significant difference in pain score between the two groups (Mann-Whitney test, p = 0.7). The 95% confidence interval for the difference in pain score was -1.0 to +3.0. ⋯ The low pain score in both groups suggests the effectiveness of distraction therapy, although factors such as skill of the operator and previous experience of the patient group are of relevance. There was no significant difference in the pain score between the EMLA and placebo groups, suggesting that in this age group if carefully selected children receive distraction during venepuncture EMLA may not be necessary.
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Randomized Controlled Trial Comparative Study Clinical Trial
Oral sucrose compares favourably with lidocaine-prilocaine cream for pain relief during venepuncture in neonates.
To compare the relative efficacy of oral sucrose versus EMLA cream for pain relief during venepuncture, 51 full-term newborns (38M, 13F; postnatal age <4 d) in a stable condition were randomly allocated to one of four treatment groups: placebo (2 ml spring water); 2 ml sucrose 24% w/v; 1 g lidocaine-prilocaine 5% cream (EMLA); or EMLA plus sucrose. Water or a single dose of sucrose solution was administered orally 2 min before venepuncture. EMLA cream was applied in the antecubital fossa 45-60 min before venepuncture and covered by a Tegaderm dressing. A pacifier was given before skin puncture, but it was not actively held or replaced during the procedure or observation periods. In total, 55 venepunctures were performed blindly, always for clinical reasons. As indicators of pain, the total crying time was recorded and heart rate, respiratory rate and arterial oxygen saturation were measured blindly at baseline, immediately post-venepuncture, and 2 and 4 min afterwards. The main effects observed were: (i) time spent crying decreased significantly in the sucrose alone (p = 0.001) and EMLA plus sucrose (p = 0.008) groups; (ii) the above treatments attenuated significantly (p < 0.05) the immediate heart rate response to pain; and (iii) the concomitant use of EMLA did not increase further the analgesic efficacy of sucrose. ⋯ This study shows that a 24% oral sucrose solution compares favourably with EMLA cream as a safe and cheap analgesic procedure to decrease pain responses to venepuncture in newborns.
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Randomized Controlled Trial Comparative Study Clinical Trial
Comparison of lignocaine-prilocaine cream and amethocaine gel for local analgesia before venepuncture in children.
The efficacy of lignocaine-prilocaine cream (EMLA) and amethocaine gel (Ametop) in reducing the pain and distress of venepuncture was compared in a single-blind randomized study of 34 children aged 1-14 y. The influences of age, anxiety and past experience were also investigated. Pain was assessed by the researcher using the Observation Scale of Behavioural Distress, and by the parent, doctor and child (if old enough) using a 10-cm, 100-point Visual Analogue Scale (VAS). ⋯ Anticipatory anxiety correlated with higher pain ratings. No differences in the analgesic effect of the two preparations were found. We conclude that whilst EMLA and Ametop are equally effective at reducing the pain of needle puncture, under some circumstances the use of Ametop may be more advantageous.