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临床试验/NCT03221946
NCT03221946已完成4 期

A Comparative Evaluation of Diclofenac Sodium Transdermal Patch, Oral Diclofenac Sodium With Intramuscular Injections of Diclofenac Sodium in Patients Suffering From Oral Pain: A Randomized Control Trial

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年1月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
90
试验地点
1
主要终点
Pain Perception scale

研究概览

简要总结

Newer drug delivery systems such as transdermal patches using pain relieving or modifying agents emerged as mainstream treatment protocol for management of pain on the outpatient basis. The administration of Diclofenac 100 mg in transdermal patch in the patients having dental pain due to periapical/periodontal infections was evaluated.

Methods: 90 Patients of either gender, between 18 to 80 years were divided into 3 groups (Group A- oral medication, Group B- transdermal patch, Group C - intra muscular group). Patients at the dental department with pain from periapical/periodontal pathologies were explained about the procedure of analgesia. With written consent, 100 mg diclofenac sodium transdermal patches were prescribed to patients who opted their use in pain control for 2 consecutive days. A Visual Analog Scale was provided for all patients assessing the pain intensity during the study.

详细描述

Transdermal Patches ensure simple, painless procedure of drug usage even in patients with needle phobia. they are on par with sustainable plasma levels comparable with that of oral medication. With the local drug delivery method, hepatic first pass metabolism is bypassed. Offering increased flexibility in placing and removing the transdermal patch better patient compliance is achieved.

This study was carried out comparing the efficacy of analgesia, occurrence of side effects from the drugs employed and patient compliance during the drug usage with diclofenac sodium trans dermal patch 100 mg, oral supplementation of diclofenac sodium 50 mg given as twice daily medication and intra muscular administration of 75 mg diclofenac sodium once daily for two days in patients having dental pain due to periapical or periodontal pathology.

Material and Methods

A total sample of 90 subjects of either gender, between 18 to 80 years attending Department of Oral Medicine & Radiology with dental pain and who were willing to be part of the study were included and divided randomly into 3 groups based on their preference and priority of the route of administration of the drug. As this was a pilot study, a sample size of 90 was chosen according to recommendations by Isaac and Michael, W. B

The study was cleared by ethical clearance committee with necessary approvals. the subjects were informed thoroughly about the study and could withdraw from the study at their choice when there is no relief of pain with the medication.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with oral and dental pain due to pulp and periapical pathology
  • patients not allergic to any form of medications in terms of NSAIDs.

排除标准

  • Unwilling and unconscious patients
  • patients with cellulitis and spreading oral infections
  • patients allergic to non steroidal anti inflammatory agents
  • patients with kidney and liver diseases
  • patients with blood disorders

研究组 & 干预措施

Diclofenac sodium oral

Active Comparator

Group A which included 30 patients of either gender. Dosage drug: Diclofenac sodium Dosage form: Oral medication Frequency: twice daily Dose: 50mg Duration: 2 days

干预措施: Diclofenac sodium (Drug)

diclofenac sodium patch

Experimental

Group B which included 30 patients who were prescribed Drug: Diclofenac sodium Dose: 100mg Drug form: transdermal patch to equate the oral dosage of 50mg Duration: for 2 days Frequency: Once daily

干预措施: Diclofenac sodium (Drug)

Diclofenac sodium injection

Other

Group C which included 30 patients of either gender Drug: diclofenac sodium intra muscular injections Dose: 75mg which was the nearest available dosage to 100 mg availability in India Frequency: once daily Duration: for 2 days

干预措施: Diclofenac (Drug)

结局指标

主要结局

Pain Perception scale

时间窗: 2 days

Measurement of pain on Visual Analog scale scores in all three groups

次要结局

  • Patient compliance - Self reported daily catalog(2 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

NALLAN CHAITANYA

Clinical Associate Professor

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

研究点 (1)

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