Liposomal lidocaine improved intravenous cannulation success rates in children
Q In children, does use of liposomal lidocaine before intravenous (IV) cannulation improve cannulation success rates and reduce pain, procedure duration, and adverse skin reactions more than placebo?
randomised placebo controlled trial.
blinded (patients and healthcare providers).
Follow up period:
immediately after first cannulation attempt.
emergency department of a children’s hospital in Toronto, Ontario, Canada.
151 children who were 1 month to 17 years of age and required a peripheral IV cannula. Exclusion criteria were critical illness requiring immediate cannulation (eg, sepsis or severe dehydration), known or suspected hypersensitivity to local anaesthetics, current administration of opioid or topical anaesthesia, or previous participation.
4% liposomal lidocaine cream, 1 g, (n = 76) or placebo (n = 75). The nurse selected 2 possible sites for cannulation and applied lidocaine or placebo cream for 30 minutes under occlusion with Tegaderm or IV 3000.
successful IV insertion on the first attempt (ie, skin was breached only once and the IV line remained in place ⩾5 minutes; a failure was recorded if a second puncture was required or if an alternate site to the 2 chosen sites was cannulated). Other outcomes included duration of procedure from first puncture to the secure of a working IV cannula, adverse skin reactions (blanching, erythema, and itchiness), and pain during cannulation (Faces Pain Scale-Revised [FPS-R]; 0 = no pain, 5 = worst pain).
Patient follow up:
94% completed the trial (mean age 6 y, 56% boys; intention to treat analysis).
Children who received liposomal lidocaine had a higher rate of cannulation success on the first attempt (table), shorter procedure duration (6.7 v 8.5 min, p = 0.04), and less pain as reported by children who were able to rate their own pain (n = 67, change from baseline FPS-R score 1.3 v 2.3, p = 0.01), parents (n = 132, 1.5 v 2.3, p<0.001), or the research assistant (n = 142, 1.3 v 2.3, p<0.001). The groups did not differ for adverse skin reactions (23% v 23%).
In children, liposomal lidocaine improved intravenous cannulation success rates on the first attempt and reduced procedure duration and pain during cannulation more than placebo. The groups did not differ for adverse skin reactions.
- Jeanette Robertson, RN, MSc, FRCNA
Since their inception in 1984, topical anaesthetics have been used widely to minimise the pain associated with needle insertion and IV cannulation. However, the hour long delay between application of topical preparations and onset of anaesthesia is an important disadvantage of these formulations. Therefore, the results of the study by Taddio et al on the effectiveness of a new shorter-acting preparation seem like a welcome addition to the knowledge base on local anaesthetics.
The strength of this trial lies in its randomisation of participants and blinding of clinicians. Results indicate that compared with placebo, liposomal lidocaine not only improved IV cannulation success rates on the first attempt, it also reduced the time taken to perform the procedure and the intensity of pain experienced during cannulation. Although these results are promising, the drug was only tested against a placebo and not against other topical anaesthetics. A more useful trial would have been to include current management as a third treatment arm. This could have informed clinicians about whether liposomal lidocaine is a shorter-acting topical anaesthetic with similar or superior properties to topical anaesthetics in current use and satisfied the regulations for testing new products against placebo to confirm the effects. It is not known whether the drug manufacturer, who partially sponsored the trial, had any input into the study design, and this may limit the value of the results to practitioners wishing to select between the available products.1 The use of parental pain assessments, which are reported to be unreliable,2 also limits the value of these findings. Further “head to head” trials that consider the outcomes already measured—in addition to patient acceptability, ease of use, and cost factors—are required to confirm the value of liposomal lidocaine before it can be recommended unequivocally.
For correspondence: Dr A Taddio, Department of Pharmacy, Hospital for Sick Children, Toronto, Ontario, Canada.
Sources of funding: RGR Pharma; Ferndale Laboratories provided liposomal lidocaine and placebo creams.