A Phase 4 interventional study of Tramadol per os (Tradonal Odis® orodispersible tablets) and Tramadol IV (Tradonal® IV) in Pain, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-01-09.
Sponsored by University Hospital, Ghent · Phase 4, Interventional, and Treatment
The purpose of this study is to compare the administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages versus tramadol IV given in 3 unit dosage of 35 mg during the first 6 hours postoperatively and to investigate the time course and accuracy of pain relief versus the onset and duration of side effects. The first unit dose will be administered at arrival at the PACU when a Visual Analogue Pain (VAS) score of more than 3 is reached. The second and third unit dose will be administered after 1 and 2 hours, respectively, when a VAS of more than 3 is observed.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.
This study's enrollment of 195 is above the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tramadol per os (Tradonal Odis® orodispersible tablets)
Drug: Tramadol per os (Tradonal Odis® orodispersible tablets)
Tramadol IV (Tradonal® IV)
Drug: Tramadol IV (Tradonal® IV)
Administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages
Administration of tramadol IV given in 3 unit dosage of 35 mg
Difference in pain score between groups
Time frame: In the first hours after anaesthesia and surgery
Difference in side-effects between the groups
Time frame: In the first hours after anaesthesia and surgery
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Ghent