Nathan 1988.
Methods | Parallel group RCT Location: USA Funding: university grant |
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Participants | Inclusion criteria: healthy children without previous dental experience requiring 4 restorative treatment visits, rated as anxious at screening visit n = 35 Age range = 48 to 72 months | |
Interventions | Group 1: no intervention Group 2: placebo inhalation (oxygen) Group 3: 20‐50:50 nitrous oxide/oxygen Inhalation, all administered by anaesthetist | |
Outcomes | Venham scale, parental questionnaire, behavioural screening instrument | |
Notes | Dr Nathan was contacted to clarify the blinding in this trial and to enquire about any unpublished trials | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomly assigned" ‐ method of sequence generation not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding ‐ Participant | Unclear risk | Study described as double‐blind. This only applies to Group 2 and Group 3 |
Blinding ‐ Operator/sedationist | Unclear risk | Study described as double‐blind. This only applies to Group 2 and Group 3 |
Blinding ‐ Outcome assessor | Low risk | Ratings of unco‐operative behaviour and anxiety were made by trained judges naive to experimental hypotheses and inhalant conditions |
Incomplete outcome assessment | Unclear risk | Numbers included/dropouts unclear |
Free of selective reporting | Low risk | All planned outcomes reported |
Free of other bias | High risk | No information on demographic characteristics at baseline |