Phase III, double-blind, randomised, placebo- and active treatment-controlled clinical trial to evaluate the analgesic efficacy and safety of a combination of ibuprofen (arginate)-tramadol hydrochloride 400-37.5 mg, administered intravenously to patients with acute severe postoperative pain.

Conditions

Acute pain

Brief summary

Sum of Pain Intensity Differences from the start of administration to 4 hours (SPID0-4h) , measured using the Numeric Rating Scale for Pain at baseline, 1 h, 2 h, 3 h and 4 h.

Detailed description

Efficacy assessment: - Sum of Pain Intensity Differences from the start of administration to 8 hours (SPID0-8h), measured using the Numeric Pain Scale at baseline, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h and 8 h., Pain intensity measured using the Numeric Pain Scale at baseline, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h and 8 h after the start of treatment., Pain intensity difference (PID) at 4 and 8 hours from the start of administration of the study medication., Time to first pain relief (↓33% pain), from the scheduled assessment intervals., Responder rate, defined as the percentage of patients with an SPID(0-4h) ≥δs., Percentage of patients using rescue medication., Time to first administration of rescue medication from the start of administration of the study medication., Total rescue medication use from start of treatment to 8 hours (measured in number of rescue doses required)., Safety assessment: Vital signs (body temperature, heart rate, blood pressure and oxygen saturation)., Safety assessment: Adverse events.

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Interventions

DRUGMORPHINE HYDROCHLORIDE

DRUGIsotone NaCl-Lösung ASmedic

DRUGTramal 50 mg

DRUGInjektionslösung

DRUGFisiológico B.Braun 0

DRUG9% Solución para perfusión

DRUGIbuprofen (arginate)-Tramadol HCl 400-37.5 mg/100 ml solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Sum of Pain Intensity Differences from the start of administration to 4 hours (SPID0-4h) , measured using the Numeric Rating Scale for Pain at baseline, 1 h, 2 h, 3 h and 4 h.	—

Secondary

Measure	Time frame
Efficacy assessment: - Sum of Pain Intensity Differences from the start of administration to 8 hours (SPID0-8h), measured using the Numeric Pain Scale at baseline, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h and 8 h., Pain intensity measured using the Numeric Pain Scale at baseline, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h and 8 h after the start of treatment., Pain intensity difference (PID) at 4 and 8 hours from the start of administration of the study medication., Time to first pain relief (↓33% pain), from the scheduled assessment intervals., Responder rate, defined as the percentage of patients with an SPID(0-4h) ≥δs., Percentage of patients using rescue medication., Time to first administration of rescue medication from the start of administration of the study medication., Total rescue medication use from start of treatment to 8 hours (measured in number of rescue doses required)., Safety assessment: Vital signs (body temperature, heart rate, blood pressure and oxygen saturation)., Safety assessm	—

Measure

Time frame

Efficacy assessment: - Sum of Pain Intensity Differences from the start of administration to 8 hours (SPID0-8h), measured using the Numeric Pain Scale at baseline, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h and 8 h., Pain intensity measured using the Numeric Pain Scale at baseline, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h and 8 h after the start of treatment., Pain intensity difference (PID) at 4 and 8 hours from the start of administration of the study medication., Time to first pain relief (↓33% pain), from the scheduled assessment intervals., Responder rate, defined as the percentage of patients with an SPID(0-4h) ≥δs., Percentage of patients using rescue medication., Time to first administration of rescue medication from the start of administration of the study medication., Total rescue medication use from start of treatment to 8 hours (measured in number of rescue doses required)., Safety assessment: Vital signs (body temperature, heart rate, blood pressure and oxygen saturation)., Safety assessm

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Countries

Spain

Outcome results

None listed