Table 4 Incidence of unexpected adverse events
Side effect | Tapentadol N = 133 | Oxycodone/Naloxone N-133 | Commentary |
|---|---|---|---|
Central-nervous side effects | |||
Confusion | 3 (0) | Confusion was observed in the immediate post-operative period, neurologic function recovered spontaneously while study medication was continued | |
Delirium | 1 (1) | Delirium developed on treatment day 2 (20/10 mg daily dose), and resolved on day4 after discontinuation of study medication | |
Convulsion | 1 (0) | Patient had a history of convulsions upon stress and sleep deprivation | |
Optical hallucinations (yellow circles) | 1 (1) | Hallucinations disappeared two days after discontinuation of study medication | |
Mood disorders | |||
Euphoria, increased talkativeness | 2 (2) | Euphoria resolved after dose reduction | |
Anxiety | 1 (1) | Anxiety and catastrophizing reaction resolved when study medication was discontinued | |
Sleeplessness and agitation | 4 (4) | Sleeplessness and agitation occurred following withdrawl of study medication | |
Cardio-vascular side effects | |||
Hypertension | 1 (0) | 1 (0) | Hypertension was noted pre-operatively |
Dysrhythmia | 1 (0) | Dysrhythmia was diagnosed pre-operatively | |
Hypotension | 1 (1) | Blood pressure was restored to normal when study medication was discontinued | |
Other minor side effects | |||
Skin rash | 1 (0) | 1 (0) | |
Sweating | 3 (1) | 5 (3) | 4 cases attributed to metamizol |
Dry mouth | 3 (3) | 2 (2) | (5) ameliorated after dose reduction |
Aching stomach, heartburn | 5 (1) | 3 (1) | (2) ameliorated after dose reduction |
Diarrhea | 1 (0) | 1 (0) | |
Headache | 1 (0) | ||