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

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ClinicalTrials.gov Identifier: NCT03221946
Recruitment Status : Completed
First Posted : July 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
NALLAN CHAITANYA, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Orofacial Pain Drug: Diclofenac Sodium Drug: Diclofenac sodium Drug: Diclofenac Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3 arms with 3 groups of 30 patients each evaluated for diclofenac sodium oral tablets, transdermal patch and injection of same drug for dental pain disorders
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 31, 2016
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : September 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Diclofenac sodium oral
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
Drug: Diclofenac Sodium
tablet of 50mg,
Other Name: Voveran

Experimental: diclofenac sodium patch
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
Drug: Diclofenac sodium
Transdermal patch 100 mg
Other Name: Sparsh

Diclofenac sodium injection
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
Drug: Diclofenac
intra muscular injection 100mg
Other Name: dicloran




Primary Outcome Measures :
  1. Pain Perception scale [ Time Frame: 2 days ]
    Measurement of pain on Visual Analog scale scores in all three groups


Secondary Outcome Measures :
  1. Patient compliance - Self reported daily catalog [ Time Frame: 2 days ]
    Self reported by patients themselves on their compliance with oral medication, transdermal patch and intra muscular injection



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221946


Locations
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India
Panineeya Institute of Dental Sciences
Hyderabad, Telangana, India, 500060
Sponsors and Collaborators
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

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Responsible Party: NALLAN CHAITANYA, Clinical Associate Professor, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
ClinicalTrials.gov Identifier: NCT03221946     History of Changes
Other Study ID Numbers: PMVIDS&RC/IEC/OMR/PR 0051-15
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diclofenac
Facial Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action