Dexketoprofen/tramadol 25 mg/75 mg: randomised double-blind trial in moderate-to-severe acute pain after abdominal hysterectomy

Table 4 Statistical analysis of SPID₈ (single-dose phase) (Primary Endpoint) (ANCOVA)

Population		Point Estimate (SE) (Treatment A)	Point Estimate (SE) (Treatment B)	Estimated Treatment Difference (SE) (Treatment A – Treatment B)	95 % CI	p-value
Treatment A	Treatment B	Point Estimate (SE) (Treatment A)	Point Estimate (SE) (Treatment B)		95 % CI	p-value
ITT population
DKP/TRAM	DKP	238 (11)	180 (11)	58 (16)	27 to 88	<0.001
DKP/TRAM	TRAM	238 (11)	153 (11)	85 (16)	54 to 116	<0.001
DKP	Placebo	180 (11)	112 (11)	68 (16)	37 to 99	<0.001
TRAM	Placebo	153 (11)	112 (11)	41 (16)	9.7 to 72	0.010
PP population
DKP/TRAM	DKP	241 (12)	184 (12)	57 (17)	24 to 90	<0.001
DKP/TRAM	TRAM	241 (12)	160 (12)	81 (17)	48 to 115	<0.001
DKP	Placebo	184 (12)	123 (12)	61 (17)	28 to 95	<0.001
TRAM	Placebo	160 (12)	123 (12)	37 (17)	3.2 to 70	0.032

SPID ₈ summed pain intensity differences over 8 h post-dose, ANCOVA analysis of covariance, DKP/TRAM dexketoprofen trometamol/tramadol hydrochloride 25 mg/75 mg, DKP dexketoprofen trometamol 25 mg, TRAM tramadol hydrochloride 100 mg, SE standard error, CI confidence interval, ITT intention-to-treat, PP per protocol. The ITT population included all patients randomised; the PP population included all ITT patients with no major protocol violations; pain intensity (PI) was measured on a 0–100 visual analogue scale (VAS) with the left end labelled “no pain” and the right end labelled “worst possible pain”; SPID was calculated as the time-weighted sum of the pain intensity difference (PID) values from baseline; SPID was tested using an ANCOVA and a two-sided overall significance level of 5 %

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