Dettagli per singolo studio

DEC-NET Serial number GB230

Published online	24/05/2004 14.16.00
Last updated	29/11/2005 10.34.16

Other protocol ID number	N0077132403
This trial has been approved by an ethics committee
Current trial status	Open (actively recruiting new participants)
First subject enrolment Target N. of subjects	12/2003 216
Major Disease (ICD9 class)	DENTAL DISORDER NOS
Experimental drug
Lignocaine Treatment regimen (dosage and duration) 0.15ml per primary tooth 0.3ml per permanent teeth - to maximum of 2ml
Control drug
IBUPROFEN Treatment regimen (dosage and duration) 10mg/kg orally (pre-op) - single dose
PARACETAMOL Treatment regimen (dosage and duration) 20mg/kg orally (pre-op) - single dose
Gender	Both
Age (range)	3-15 years
Eligibility criteria
Inclusion criteria
- Admitted to Derbyshire Children's Hospital for tooth extraction under general anaesthetic - Child able to be observed on Sunflower ward for 1 hour post surgery
Exclusion criteria
- Parents have a poor command of English or require translation so as unable to give full informed consent - Children with known cardiac disorders and those taking antiarrhythmics or Beta-Blockers - Children suffering with porphyria - Children known to have liver or renal impairment
Trial design/methodology
Phase	4
Kind of study	Efficacy Safety
Design	Controlled Randomised Blinded Double blind
Purpose of study
To evaluate the intraligamental injection (injection into periodontal ligament of a tooth) of a local anaesthetic, lignocaine, carried out prior to the extraction of teeth, in children undergoing 1) extraction of primary teeth and 2) primary and permanent teeth.
Primary outcomes
A 50% decrease in the total pain score over the first hour after tooth extraction in the group treated with intraligamental lignocaine
Secondary outcomes
No increase in pain for the children at home once the local anaesthetic action has finished
Summary of study design, objectives, and ongoing research findings
All parents informed by letter or during the pre hospital appointment that the study is taking place. Prior to theatre, on the morning of the child's operation, informed consent will be obtained from a parent or guardian. All children attending for tooth extraction under the care of Dr Quirke will be entered into the study if parents agree. Power calculations, based on a previous study, showed that 32 children were needed in each group in order to detect a difference of 50% in the mean pain scores in the first hour postoperatively (90% power, 5% significance level). Four groups will be needed 1) primary tooth extraction 2) primary tooth extraction controls and 3) primary tooth and permanent tooth extraction 4) primary tooth and permanent tooth extraction controls. The total will b 128 children. The children will then be randomised by Dr Sammons using block randomisation with envelopes. They will then receive either 2% Lignocaine solution with adrenalin (epinephrine) 1:80,000 injected intraligamentally by Dr Quirke during the operative procedure or no treatment. Each primary tooth will require 0.15ml and permanent teeth approx. 0.3ml.The maximum dose used will be 2 mls . A standard anesthetic routine will be used for the procedure by Dr A Boyd (Consultant Anesthetist). Regular pain assessments will be performed at 5, 10,15 and 30 minutes on the child's return from theatre. This will be done by Vanessa Peden who will be blinded to the child' treatment. The children's pain will be assessed using the TPPS (Toddler-Preschooler Post Operative Pain Scale), which has been validated in children 1-5 years. In the older children above the age group for which this tool is validated, we will ask them to self report their pain using the Wong and Baker faces score which is validated from 4 years and above. Adverse events will be elicited by observation during and immediately after the procedure by investigators and by the follow up telephone conversations 24 hrs and 7 days post op. Once the child is discharged home the parents will be asked to score their child's pain every hour for the next five hours or until their child goes to bed, and to record if any further analgesia is needed. This will be done using a diary and the Wong and Baker faces score for self reporting. This will be followed up by a phone call the morning after the procedure an one a week post operatively. Please note this trial is currently on hold - reason for this withheld.