Anand 2005.
| Methods | Study design: 2‐arm split mouth randomised trial Conducted in: UK Number of centres: 1 Setting: dental hospital Recruitment period: unclear Funding source: not reported |
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| Participants | Inclusion criteria: ASA I ‐ II required symmetrical extractions Exclusion criteria: children in whom LA was contraindicated, children with learning difficulties Number of participants randomised/evaluated: total = 30 (13 males, 17 females) Mean age (years) = 11.3 (SD = 1.7) |
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| Interventions | Group 1: ITR, 0.2 ml bupivacaine (0.5%) with 1:200000 adrenaline intraligamentary per root Group 2: NLA |
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| Outcomes | Postoperative visual analogue scales and questionnaire Measured at waking, 2 to 3 days postoperatively |
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| Notes | GA procedure: maintained with nitrous oxide/sevoflurane Co‐interventions: Systemic analgesics were given intraoperatively (IV ketorolac, IV alfentanil, suppository diclofenac sodium). Oral paracetamol or ibuprofen was also given on discharge Declarations of interest: none reported There was no sample size calculation |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Each patient acted as his / her own control using a half‐mouth study design. One side of the mouth was randomly selected for administration of ILA by one of 3 operators" Comment: The paper did not state the method of sequence generation |
| Allocation concealment (selection bias) | Unclear risk | The paper did not describe the method of allocation concealment |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The same operator who administered the LA performed all the dental extractions" Comment: The study blinded participants |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "...keeping the principal investigator blind to the side of analgesia" Quote: "The principal investigator carried out all postoperative assessments and interviews" Comment: The study blinded assessors |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | The outcome evaluation included all participants |
| Selective reporting (reporting bias) | Low risk | The study reported all expected outcomes |
| Other bias | Low risk | There was no other apparent bias |