| Methods |
Randomised, parallel group, double blind study |
| Participants |
242 participants randomised to 4 groups, no withdrawals
Number randomised to Intervention A: male 27, female 33, mean age 24.5
Number randomised to Intervention B: male 26, female 34, mean age 26.2
Number randomised to Placebo A: male 21, female 41, mean age 25.0
Number randomised to Placebo B: male 24, female 36, mean age 24.6
Number of third molars removed per patient, in both groups: 1
Mean baseline intensity Intervention A: categorical 2.00 (moderate 60) VAS 49.4
Mean baseline intensity Intervention B: categorical 2.00 (moderate 60) VAS 47.3
Mean baseline intensity Placebo A: categorical 2.00 (moderate 61, severe 1) VAS: 50.5
Mean baseline intensity Placebo B: categorical 2.00 (moderate 61) VAS: 47.6
Setting: Department of Oral and Maxillofacial Surgery, Royal Dental College, Aarhus (Denmark) |
| Interventions |
Intervention A: Paracetamol 1000 mg versus Placebo A
Formulation: effervescent tablets
Intervention B: Paracetamol 1000 mg versus Placebo B
Formulation: tablets
Anaesthesia: not stated |
| Outcomes |
PI at 4 hours: categorical scale 0‐3 (none ‐ severe) VAS scale 0‐100 mm (no pain ‐ worst possible pain)
PR at 4 hours: categorical 0‐4 (none ‐ complete)
Global assessment: categorical 0‐3 (poor ‐ excellent)
Adverse effects reported as total number of adverse events, and number of patients with adverse events |
| Notes |
Sponsored by
Bristol Myers Squibb |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
