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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

Primary Purpose

Orofacial Pain

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Diclofenac Sodium
Diclofenac sodium
Diclofenac
Sponsored by
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orofacial Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Panineeya Institute of Dental Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Other

Arm Label

Diclofenac sodium oral

diclofenac sodium patch

Diclofenac sodium injection

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient compliance - Self reported daily catalog
Self reported by patients themselves on their compliance with oral medication, transdermal patch and intra muscular injection

Full Information

First Posted
July 12, 2017
Last Updated
December 18, 2017
Sponsor
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03221946
Brief Title
A Comparative Evaluation of Diclofenac Sodium Transdermal Patch, Oral Diclofenac Sodium With Intramuscular Injections of Diclofenac Sodium in Patients Suffering From Oral Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 31, 2016 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
September 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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. The groups included in the study were: Group A which included 30 patients of either gender who were prescribed tablet Diclofenac sodium 50 mg orally twice daily for 2 days which is the preferred adult dose for dental pain disorders Group B which included 30 patients who were prescribed Diclofenac sodium 100mg transdermal patch to equate the oral dosage of 50mg that is given twice daily once daily for 2 days ( SPARSH PHARMA). It is a transparent patch that gave sustained release of the drug for 24 hours at the local site applied. A total number of 2 patches were given to each patient one per day. The patches were applied at an hairless area on the left or right shoulders which were subsequently replaced the next day to another area of application in order to avoid contact dermatitis in the area of application. Group C which included 30 patients of either gender who were given intra muscular injection of 75mg which was the nearest available dosage to 100mg availability in India at deltoid or gluteus muscle once daily for 2 days using sterile and aseptic precautions. All the subjects were prescribed necessary antibiotics for reduction in peri apical /periodontal infections. The rescue medication tablet chosen was Paracetamol 325 mg, if any of the patients opted for further medication for pain relief. Also, a visual analog scale was provided to all the subjects during their presentation to the hospital for 2 consecutive days for treatment. the scales were obtained in all the subjects individually assessing the intensity of pain after the medication intake during the study period. Team of six doctors evaluated the patients in the study. 2 physicians were assigned the task of data collection from the study participants and assigning them into the group chosen by the patients themselves. 2 physicians had evaluated the patients VAS scores clinically and administered the necessary medication to the patients and rest of the doctors had evaluated the patients at each visit, making a note of inter observer variability. The enquiry of following adverse effects were noted from all 3 groups. Group A: Rash, Itch, Gastritis Group B: Rash at the delivery site, adherence of patch Group C: Pain at injection site, Nerve palsy, Hypersensitivity reactions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orofacial Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diclofenac sodium oral
Arm Type
Active Comparator
Arm Description
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
Arm Title
diclofenac sodium patch
Arm Type
Experimental
Arm Description
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
Arm Title
Diclofenac sodium injection
Arm Type
Other
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Diclofenac Sodium
Other Intervention Name(s)
Voveran
Intervention Description
tablet of 50mg,
Intervention Type
Drug
Intervention Name(s)
Diclofenac sodium
Other Intervention Name(s)
Sparsh
Intervention Description
Transdermal patch 100 mg
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Other Intervention Name(s)
dicloran
Intervention Description
intra muscular injection 100mg
Primary Outcome Measure Information:
Title
Pain Perception scale
Description
Measurement of pain on Visual Analog scale scores in all three groups
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Patient compliance - Self reported daily catalog
Description
Self reported by patients themselves on their compliance with oral medication, transdermal patch and intra muscular injection
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Panineeya Institute of Dental Sciences
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500060
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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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