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. 2018 Dec 17;2018(12):CD003877. doi: 10.1002/14651858.CD003877.pub5

Nathan 1988.

Methods Parallel group RCT
Location: USA
Funding: university grant
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Notes Dr Nathan was contacted to clarify the blinding in this trial and to enquire about any unpublished trials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