Efficacy of Naproxen-codeine, Naproxen+Dexamethasone, and Naproxen on Myofascial Pain

NCT04066426 | Completed Phase 4 Results

• 1 other identifier: 16.02.2018/12
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Temporomandibular disorders (TMDs) are one of the most common muco-skeletal disorders, seen in the dental clinics. Many factors work together to initiate or aggravate the condition, so it is a multifactorial disorder. The etiology of TMDs may be a result of parafunctional habits such as clenching and bruxism, acute trauma to the jaw, trauma from hyperextension e.g. after a long dental treatment, joint laxity, psychological distress, occlusal disharmony like presence of high crown or free-end saddle leading to joint instability or systemic diseases such as Rheumatoid arthritis or Osteoarthritis. The aim of this study was to evaluate the effects of naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, and naproxen sodium on pain in patients complaining from temporomandibular pain.

Conditions

Temporomandibular Disorder

Keywords

naproxen sodium; codeine phosphate; dexamethasone; pain; temporomandibular joint

Outcome Measures

Primary Outcomes (4)

• Pain Evaluation

  Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain)

  Pre-treatment (baseline)

• Pain Evaluation

  Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).

  At the first week

• Pain Evaluation

  Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).

  At the second week

• Pain Evaluation

  Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).

  At the first month

Study Arms (4)

naproxen sodium+codeine phosphate

EXPERIMENTAL

Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Codeine phosphate is an opioid analgesic which has similar applications to those of morphine. However, it is significantly less potent as an analgesic and has only mild sedative effects. The drug's principal site of action is at the µ-opioid receptors (MOR) which are distributed in the central nervous system. Peak effect is reached within 2 hours and analgesic action continues for approximately 4 hours. Naproxen sodium (550 mg)+codeine phosphate (30 mg) was used twice daily in this study.

Drug: naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol

naproxen sodium+dexamethasone

EXPERIMENTAL

Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily + dexamethasone (8 mg) was used once daily in this study.

Drug: naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol

naproxen sodium

EXPERIMENTAL

Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily in this study.

Drug: naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol

paracetamol

ACTIVE COMPARATOR

Paracetamol is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine, toothache, neuralgia, colds and influenza, sore throat, backache, rheumatic pain and dysmenorrhoea.

Drug: naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol

Interventions

naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol DRUG

NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.

Also known as: Anaprox Double Strength (DS) + Codeine, Anaprox DS + Decadron, Anaprox DS, Parmol

naproxen sodium; naproxen sodium+codeine phosphate; naproxen sodium+dexamethasone; paracetamol

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Without a systemic disease,
• Not used any medication in the last week
• Have a habit of clenching and / or grinding teeth, individuals with normal preoperative results, suffering with pain and / or limitation of the mouth opening in the temporomandibular region

You may not qualify if:

• Individuals who smoke
• Have a parafunctional habits (except for squeezing and grinding teeth)
• Pregnant and breastfeeding individuals
• Allergies to study medicines
• Do not use their medications / use different drugs and non-follow-up

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yuzuncu Yil University, Faculty of Dentistry

Van, Tuşba, 65080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Pain

Interventions

Naproxen; Acetaminophen; Codeine; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Benzenesulfonates; Benzene Derivatives; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Limitations and Caveats

The diversity of the individuals in the groups was the limitation of this study. Different individual characteristics may change the efficacy of drugs in groups.

Results Point of Contact

• Title: Dr. Volkan Kaplan
• Organization: Tekirdag Namik Kemal University

dr.volkankaplan61@gmail.com

+90282250000

Study Officials

• Volkan KAPLAN, PhD

  Cairo University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Oral and Maxillofacial Surgery Department

Study Record Dates

• First Submitted: August 17, 2019
• First Posted: August 26, 2019
• Study Start: March 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: July 15, 2019
• Last Updated: February 15, 2021
• Results First Posted: February 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)