Impact of Tramadol Addiction On Dental Anesthesia Success

NCT05908305 | Unknown Phase 4

• 1 other identifier: Tramadol Addict Impact On Dent
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim is to investigate and to find a correlation between tramadol addiction misuse among Algerian males and Dental Local Anesthesia success while performing dental care and oral surgeries.

Conditions

Dental Pain and Sensation Disorder; Anesthesia, Local; Addiction, Opioid

Keywords

Tramadol; Addiction; Local Anesthesia; Dentistry; Carpule

Outcome Measures

Primary Outcomes (2)

• Measuring in (ML) the quantity of dental anesthesia used in each participants group to achieve analgesic effect

  The quantity (ml) of dental anesthesia used to perform dental and oral surgery procedure among tramadol addicted and non-addicted patients will be mesured to investigate the difference.

  3 months

• To determine the number of dental anesthesia carpules used for each group participants during dental and oral procedures

  Among addicted and non-addicted patients, the number of carpules of dental anesthesia necessary for total analgesic effect will be determined.

  3 months

Secondary Outcomes (1)

• To determine the quantity ( mg) of tramadol and the time of consumption ( in months) necessary to cause dental anesthesia failure among addicted patients.

  3 months

Study Arms (2)

Tramadol Addicted Patients

ACTIVE COMPARATOR

It represents the group of tramadol addicted patients seeking dental care that require dental anesthesia.

Drug: articaine@ (4% 1:100000 epinephrine) dental anesthesia

Non addicted patients

ACTIVE COMPARATOR

The group of patients requiring dental care with local anesthesia and who are not addicted to tramadol.

Drug: articaine@ (4% 1:100000 epinephrine) dental anesthesia

Interventions

articaine@ (4% 1:100000 epinephrine) dental anesthesia DRUG

Administration, calculation and adjustment of dental local anesthesia doses.

Also known as: mepivacaine@ (2%@ 1:100000 epinephrine) dental anesthesia

Non addicted patients; Tramadol Addicted Patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Only males will be recruited since this topic is somehow stigma in Algeria. Drugs abusive use in Algeria is found among males and females but considered for religious and society related reasons a stigma.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males
• ≥18 years old \<65
• Without comorbid conditions (Hypertension, diabetes, Asthma etc..)
• Tramadol addicted (regular tramadol user)
• Only tramadol addicted, if any other drugs are regularly consumed, the patient is excluded.

You may not qualify if:

• Females
• ˂ 18 years old
• With comorbid conditions (HTN, diabetes, epilepsy etc..)
• ≥ 65 years old men.
• Not addicted to tramadol or addicted to other drugs with it.

Sponsors & Collaborators

• University of Algiers: lead

Related Publications (4)

• Carnaval TG, Sampaio RM, Lanfredi CB, Borsatti MA, Adde CA. Effects of opioids on local anesthesia in the rat: a codeine and tramadol study. Braz Oral Res. 2013 Nov-Dec;27(6):455-62. doi: 10.1590/S1806-83242013000600003.

  PMID: 24346042 BACKGROUND

• Guven M, Mert T, Gunay I. Effects of tramadol on nerve action potentials in rat: comparisons with benzocaine and lidocaine. Int J Neurosci. 2005 Mar;115(3):339-49. doi: 10.1080/00207450590520948.

  PMID: 15804720 BACKGROUND

• Premnath S, Alalshaikh G, Alfotawi R, Philip M. The Association Between Coffee Consumption and Local Anesthesia Failure: Social Beliefs and Scientific Evidence. Cureus. 2020 Apr 24;12(4):e7820. doi: 10.7759/cureus.7820.

  PMID: 32467795 BACKGROUND

• Fung EY, Giannini PJ. Implications of drug dependence on dental patient management. Gen Dent. 2010 May-Jun;58(3):236-41; quiz 242-3.

  PMID: 20478804 BACKGROUND

MeSH Terms

Conditions

Toothache; Sensation Disorders; Opioid-Related Disorders; Behavior, Addictive

Interventions

Carticaine; Epinephrine; Anesthesia, Dental; Mepivacaine

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Anesthesia; Anesthesia and Analgesia; Dentistry; Piperidines

Central Study Contacts

Mohammed Amir Rais, DMD

CONTACT

+213696988763; raismohammedamir@gmail.com

Mohammed Amir Rais

CONTACT

+213696988763; raismohammedamir@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Dentists providing dental care participating in the study are masked.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Assessing local dental anesthesia success while performing different dental care among Algerian males addicted or not addicted to tramadol.

Study Record Dates

• First Submitted: December 4, 2022
• First Posted: June 18, 2023
• Study Start: June 10, 2023
• Primary Completion: September 29, 2023
• Study Completion: October 15, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06