Dettagli per singolo studio

DEC-NET Serial number GB266

Published online	30/06/2004 12.47.00
Last updated	19/07/2006 10.28.25

Other protocol ID number	N0072119583
This trial has been approved by an ethics committee
Current trial status	Published in public domain
First subject enrolment Target N. of subjects	05/2003 77
Major Disease (ICD9 class)	URTICARIA NOS
Experimental drug
Amethocaine Gel Treatment regimen (dosage and duration) Applied locally prior to venepuncture. The contents of half a tube (0.5g) of amethocaine was applied to both the antecubital fossa (elbow) and the dorsum (back) of the hand was applied for 30 minutes after which time the gel was removed with a gauze swab.
Gender	Both
Age (range)	1month - 16years
Eligibility criteria
Inclusion criteria
Children aged 1 month - 16 years requiring venepuncture. Attending the children's outpatients clinic at the Countess of Chester for venepuncture as part of their normal treatment. Visible veins were required at both sites, the antecubital fossa and the dorsum of the hands
Exclusion criteria
1. Infants less than one month of age 2. Children with a previous reaction to Ametop or other local anaesthetic preparations were excluded. Ametop was not applied to wounds or areas of broken skin
Trial design/methodology
Phase	4
Kind of study	Safety
Design	Observational
Purpose of study
To quantify the frequency of urticarial reactions occurring when Ametop Gel is used prior to venepuncture. To determine if urticarial reactions are more frequent at particular sites and in particular to try and confirm that the anti-cubital fossa is the principle site for local reactions as highlighted in the original audit.
Primary outcomes
Of the 77 children taking part in this study 35 children had either no reaction or an erythematous reaction whilst 42 experienced an urticarial reaction, blistering was not observed in any participant. All participants who experienced an urticarial reaction had a reaction at the antecubital fossa, four of these also had urticarial reactions on the dorsum of the hand, and 1 had an erythematous reaction on the dorsum of the hand. Results of McNemar's test indicated a statistically significant increase in the proportion experiencing a reaction at the elbow (p<0.001).
Secondary outcomes
No association was identified between reaction and sex (chi-square test p=0.28). A statistically significant association was identified between age and reaction (Cochrane-Armitage exact test for trend p=0.0002)with the youngest been more likely to get a urticarial reaction.
Summary of study design, objectives, and ongoing research findings
A within group (paired) comparison study. Children attending an outpatient department for venepuncture as part of their normal treatment had Ametop gel applied to the elbow and the dorsum of the hand. To identify the incidence of children who have local reactions to (Amethocaine) Ametop gel and to identify whether site and age are important factors in the occurrence of local reactions. This study does confirm that there is an increased frequency of urticarial reaction when Ametop is used at the antecubital fossa compared with the dorsum of the hand. The frequency of reactions increases when the product is used in younger children.We recommend that the use of Ametop should be confined to the dorsum of the hand wherever possible. Should the antecubital fossa need to be accessed an alternative product should be considered.