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Stability and Analgesic Efficacy Study for a Mixture of Diltiazem, Lidocaine and Diclofenac Gel Formulations in Post Hemorrhoidectomy Pain Reduction in Iraqi Patients
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| Author:
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QASIM A.BADER, HAITHEM R. MOHAMMED, ZAHRAA S.HATEF
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| Abstract:
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Objective: to evaluate the analgesic efficacy of fixed-dose topical gel mixture of diclofenac, lidocaine and diltiazem (DLD) compared with a fixed dose topical gel mixture containing lidocaine and diclofenac (LD) to treat POP after hemorroidal surgery during the first postoperative week.
Methods: Both mixtures were prepared by direct mixing in different proportions and investigated by visual inspection (color, texture, and odor and gel uniformity), pH and Viscosity Possible chemical interactions were studied by tracing IR peaks for each drug under study. It is a randomized, double-blind and controlled clinical pilot with parallel group it was designed to last one week after operation and performed on 160 patients aged from 18-60 years old with specified inclusion criteria.
Results: All the prepared formulations were uniform under visual inspection, pH, viscosity values and the drugs had normal IR spectrum after mixing. The mean decrement in the pain severity according to (VAS ruler) seems greater in DLD group (8.66 ± 1.09) compared with LD gel group (3.92 ±1.334). After treatment for 6 days postoperatively, pain reduction is significantly greater in the group applied DLD (6.463 ± 2.39) than in the LD group (4.055 ± 3.11). AUC exhibit higher effectiveness for DLD than for LD group for 3 and 6 days postoperatively.
Conclusion: The new topical combination of diltiazem gel, diclofenac gel and lidocaine gel DLD is recognized to be more effective than application of diclofenac and lidocaine LD in the 1st three post-operative days and all over the 1st week next hemorrhoidectomy
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| Keyword:
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DLD, LD, POP, VAS, hemorroidectomy.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2020.SP2.333
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| Download:
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