Effect of paracetamol-codeine compared to placebo on surgical discomfort and post-traumatic stress disorder symptoms following mandibular third molar removal: a prospective randomized clinical trial
Abstract
This study investigated the impact of a single, pre-emptive 500 mg paracetamol plus 7.5 mg codeine phosphate dose on surgical discomfort, anxiety, post-traumatic stress disorder (PTSD) symptoms, and pain during mandibular third molar extraction. Patients were randomized to receive either the drug combination or a placebo.Preoperative anxiety was assessed using the State-Trait Anxiety Inventory (STAI), Dental Anxiety Scale (DAS), and anxiety visual analogue scale (Anxiety-VAS). Post-surgery, discomfort was measured with the Self-Perception Questionnaire of Dentoalveolar Oral Surgery (QCirDental), while pain and anxiety were assessed using VAS scales. Patients also maintained a postoperative pain diary. On day 7, the Impact of Event Scale-Revised (IES-R) evaluated surgery-related PTSD symptoms.Sixty patients completed the study (30 per group), with similar demographics and surgical characteristics. Results indicated no significant difference in anxiety (STAI, DAS, Anxiety-VAS) between groups. The pre-emptive medication was similarly effective to placebo for managing anxiety, intraoperative discomfort, and postoperative pain.A stressful surgical event was observed in 13.3% of patients, leading to clinical concern or probable oral surgery-related PTSD. However, the paracetamol-codeine group did not show improved overall IES-R scores. Ultimately, a single pre-emptive dose of 500 mg paracetamol plus 7.5 mg codeine phosphate offered no additional benefits in mandibular third molar…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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