Nieuwenhuizen 2013.

Methods	Study design: randomised controlled trial, parallel design Location: Netherlands Number of centres: 3 Setting: 3 paediatric practices but unclear which setting Recruitment period: over the period of 4 months, year not specified Funding source: not reported
Participants	Inclusion criteria: need routine restorative dental treatment under LA, children not on special education Number of participants randomised: 118 children Number of participants evaluated: 112 children Number of males/females: 59 males and 59 females Age range: 4 to 6 years Mean age: 66 months, SD: 9 months (mean age Group 1: 65.3; mean age Group 2: 66.5)
Interventions	Group 1 (control): LA delivered with the wand Group 2: LA delivered using Sleeper One
Outcomes	Children were video taped and assessed by 2 independent observers Pain‐related behaviour: using a modified Wong‐Baker Faces scale ‐ fixed protocol every 15 seconds. Looking at body movement, muscle tension, crying and screaming, verbal protest and bodily resistance. The frequency of the behaviour was divided by the total number of intervals scored Distress: measured using a Venham (modified) clinical rating of anxiety and co‐operative behaviour. This was rated from 0 (relaxed ) to 5 (out of contact/untreatable). The highest score in the appointment was used Self‐reported pain: using a faces pain scale‐revised Dental anxiety: using the Dental Subscale of the Children's Fear Survey Schedule (CFF‐DS). This was completed by the parents and a threshold of 32 was used to determine low (below 32) and high anxiety (over 32). Not clear when the parents completed this. Preoperative anxiety only (without comparison to a postoperative measurement of anxiety) is not an outcome for this review, as unsure of when this was undertaken, it was not included
Notes	No sample size calculation 2 independent observers had a interexaminers agreement with a Cohen's kappa of 0.94 Consent and ethical approval obtained
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "each child was assigned to the use of either the WAND or Sleeper One based on a randomisation list generated by SPSS (SPSS, 17,0: Chicago, IL, USA)
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of participants and personnel (performance bias) All outcomes	High risk	It was not discussed if the patient was blinded to treatment. Not reported whether operators were blinded, but it would be impossible to blind operators to the intervention as 2 different devices were used
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "The observers were aware of the type of CCLAD used"
Incomplete outcome data (attrition bias) All outcomes	High risk	5 children were excluded due to difficulties with video and 1 was a child with special needs. No description of which group these children were included in
Selective reporting (reporting bias)	Low risk	All recorded outcomes were reported on within the results section
Other bias	High risk	6 children were found to have high bone density and for that reason it was not possible to deliver intraosseous LA. Intraligamental anaesthetic was delivered, however there is no description as to which group were these children included. This may have introduced bias into the results