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Post-Operative Paralytic Ileus for trimebutine maleate

Time:2015/9/30 7:27:21

Controlled Studies: Five controlled and 11 open studies were performed to evaluate the clinical effects of trimebutine maleate on postoperative ileus. These studies included

1,123 patients (controlled studies: 340 patients, and open studies: 783 patients).

In the controlled studies, trimebutine maleate was administered at doses of 100 to 400 mg by intravenous or intramuscular routes. Overall results indicated that trimebutine 


maleate was well tolerated by patients. The time interval to passage of first intestinal gas was shorter in trimebutine maleate treated patients (52 ± 9 hours) as compared to 


placebo group (73 ± 17 hours). Also, the resumption of intestinal motility was significantly faster (68 ± 11 hours) in comparison with placebo (88 ± 18 hours) (p<0.05). In 


addition, patients in trimebutine maleate group felt less abdominal discomfort than those in placebo group.

Adverse side effects, such as dizziness, nausea and/or vomiting, diarrhea and dry mouth,were reported by 14 of 340 patients (4.1%). These adverse effects were mild in nature

and did not require concomitant medication.

Open Studies: In the 11 open studies, resumption of gases appeared within 48 hours in 66.4% of cases while in 85.4% it appeared within 72 hours. As in the controlled studies,

trimebutine maleate helped in improving the postoperative conditions of patients as their abdominal and colonic discomfort, abdominal pain and nausea decreased. 


Results indicated that trimebutine maleate had an intense contractile activity on the intestine of the 29 patients treated with the drug compared to 13 patients who did not

receive it. Clinically, the study showed that the duration of paralytic ileus was notably shorter in patient treated with trimebutine maleate than in the control group. The 


passage of the first postoperative gas was reduced by an average of 23% by trimebutine maleate.

It was also noted that trimebutine maleate attenuated the symptoms associated with ileus,namely nausea, vomiting, distention and abdominal pain.