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

NCT03221946 | Completed Phase 4 DMC

• 1 other identifier: PMVIDS&RC/IEC/OMR/PR 0051-15
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Orofacial Pain

Outcome Measures

Primary Outcomes (1)

• Pain Perception scale

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

  2 days

Secondary Outcomes (1)

• Patient compliance - Self reported daily catalog

  2 days

Study Arms (3)

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

Drug: Diclofenac Sodium

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

Drug: Diclofenac sodium

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

Drug: Diclofenac

Interventions

Diclofenac sodium DRUG

tablet of 50mg,

Also known as: Voveran

Diclofenac sodium oral

Diclofenac DRUG

intra muscular injection 100mg

Also known as: dicloran

Diclofenac sodium injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre: lead

Study Sites (1)

Panineeya Institute of Dental Sciences

Hyderabad, Telangana, 500060, India

Location

MeSH Terms

Conditions

Facial Pain

Interventions

Diclofenac; dicloran

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 19, 2017
• Study Start: January 31, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 15, 2017
• Last Updated: December 19, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)