Gay-Escoda C, Hanna M, Montero A, et al. Tramadol/dexketoprofen (TRAM/DKP) compared with tramadol/paracetamol in moderate to severe acute pain: results of a randomised, double-blind, placebo and active-controlled, parallel group trial in the impacted third molar extraction pain model (DAVID study) BMJ Open 2019;9:e023715. doi: 10.1136/bmjopen-2018-023715.
This article was previously published with some errors.
The author name ‘Giustino Varassi’ should be ‘Giustino Varrassi’.
In the results section of the abstract, Mean (SD) TOTPAR6 in the active control groups should be 9.2 (7.65) instead of 9.1 (7.65).
In table 2, the data for 4≤ NRS-PI ≤6 (n, %) and NRS-PI >6 (n, %) under Pain intensity (NRS-PI) was incorrect. The correct data is as follows:
| TRAM/DKP, n=260 |
TRAM/paracetamol, n=262 |
Placebo, n=131 |
|
| 4≤ NRS-PI ≤6 (n, %) | 196 (75.4) | 210 (80.2) | 102 (77.9) |
| NRS-PI >6 (n, %) | 63 (24.2) | 52 (19.8) | 29 (22.1) |
There were some incorrect data in table 3, which are listed below:
For parameter TOTPAR, the data under TRAM/paracetamol, n=262 and Placebo, n=131 was incorrect for 4, 6 and 8 hours. The correct data is as follows:
| TRAM/paracetamol, n=262 |
Placebo, n=131 |
||
| Parameter | Time Points | Mean (SD) | Mean (SD) |
| TOTPAR | 4 hours | 6.5(4.95) | 1.5 (2.71) |
| 6 hours (primary endpoint | 9.2 (7.65) | 1.9 (3.89) | |
| 8 hours | 11.3 (10.15) | 2.4 (5.23) |
The Mean (SD) at Placebo, n=131 for the parameter % max SPID should be 2.4(23.07) and not 2.4 (23.06)
The expansion of TOTPAR provided in footnote is total pain relief over 6 hours whereas it should be total pain relief.
In figure 2, the label of last group of bars was wrongly spelled as TOTPARS8, whereas it should be TOTPAR8. In caption, it should be TOTPAR, total pain relief and not TOTPAR6, total pain relief.
In figure 3, the correct values of Mean PAR on the y-axis are 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0 and 3.5. The values 0, 1, 1, 2, 2, 3, 3 and 4 are incorrect. *represents ‘Statistically significant TRAM/DKP versus TRAM/paracetamol (p<0.0001)’. ††signifies ‘Statistically significant TRAM/DKP versus TRAM/paracetamol (p<0.00086)’. In both the cases, the position of the drugs, TRAM/DKP and TRAM/paracetamol, is interchanged.
In Table 4, the expansion of TOTPAR in footnote is total pain relief over 6 hours, whereas it should be total pain relief.
In Figure 4, ††signifies TRAM/DKP versus TRAM/paracetamol (p=0.0052). The position of the drugs, TRAM/DKP and TRAM/paracetamol, is interchanged.
Likewise, in Table 6 *stands for Statistical test TRAM/DKP versus TRAM/paracetamol (p<0.0001). The position of the drugs, TRAM/DKP and TRAM/paracetamol, were interchanged.
In the third paragraph of Secondary endpoints under Efficacy results, the median (95% CI) times to confirmed MPAR after single dose of TRAM/DKP was 41 (33 to 45) min and not 42 (33 to 45). Therefore, the correct sentence is:
The median (95% CI) times to confirmed FPPAR and MPAR after single dose of TRAM/DKP were 22 (18 to 24) and 41 (33 to 45) min, respectively; while the ones in the TRAM/paracetamol group were 27 (23 to 27) and 57 (49 to 57) min, respectively.