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Impact of Tramadol Addiction On Dental Anesthesia Success

Primary Purpose

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

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
articaine@ (4% 1:100000 epinephrine) dental anesthesia
Sponsored by
University of Algiers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Dental Pain and Sensation Disorder focused on measuring Tramadol, Addiction, Local Anesthesia, Dentistry, Carpule

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Tramadol Addicted Patients

    Non addicted patients

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    To determine the quantity ( mg) of tramadol and the time of consumption ( in months) necessary to cause dental anesthesia failure among addicted patients.
    As our hypothesis suggested that tramadol addiction cause dental anesthesia failure, we would like to calculate the dose and number of months of tramadol consumption necessary to provok dental anesthesia failure as an addiction complication

    Full Information

    First Posted
    December 4, 2022
    Last Updated
    June 8, 2023
    Sponsor
    University of Algiers
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05908305
    Brief Title
    Impact of Tramadol Addiction On Dental Anesthesia Success
    Official Title
    Study of Tramadol Addiction Impact on Dental Anesthesia Succes.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 10, 2023 (Anticipated)
    Primary Completion Date
    September 29, 2023 (Anticipated)
    Study Completion Date
    October 15, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Algiers

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Local anesthesia is by far the most important part of pain control in dentistry, it is the cornerstone that makes many dental procedures possible, not only for the patient but also for the dentist and dental hygienists. Since the pain and the dentist are almost synonymous for the patient, this makes dental anesthesia the most widely administered drugs in the dental clinics. Hence, the failure of local anesthesia in oral medicine presents an undesirable outcome both for the patient and for the practitioner. The intraoperative pain being prevented by the administration of a local anesthesia must be followed by the management of the postoperative pain which can be often intense and thus requiring drugs administration. These drugs could be nonopioid or opioid analgesics which are also frequently used in general medicine as Tramadol. Tramadol is 2-(dimethyl amino)-methyl)-1-(3'-methoxyphenyl) cyclohexanol hydrochloride. It is 4-phenyl-piperidine analogue of the opioid drug codeine. It is generally well tolerated with few and rare side effects. Moreover, comparative studies have mostly shown that Tramadol is more effective than NSAIDs for post operative pain control. However, its misuse is increasingly growing and has become obvious in Algeria. Tramadol addiction has become very frequent, and its unjustified use is expanding. This might be attributed to the fragility of the health system and the replacement of the qualified pharmacists by non-qualified helpers or assistants.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Pain and Sensation Disorder, Anesthesia, Local, Addiction, Opioid
    Keywords
    Tramadol, Addiction, Local Anesthesia, Dentistry, Carpule

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Assessing local dental anesthesia success while performing different dental care among Algerian males addicted or not addicted to tramadol.
    Masking
    Care Provider
    Masking Description
    Dentists providing dental care participating in the study are masked.
    Allocation
    Non-Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tramadol Addicted Patients
    Arm Type
    Active Comparator
    Arm Description
    It represents the group of tramadol addicted patients seeking dental care that require dental anesthesia.
    Arm Title
    Non addicted patients
    Arm Type
    Active Comparator
    Arm Description
    The group of patients requiring dental care with local anesthesia and who are not addicted to tramadol.
    Intervention Type
    Drug
    Intervention Name(s)
    articaine@ (4% 1:100000 epinephrine) dental anesthesia
    Other Intervention Name(s)
    mepivacaine@ (2%@ 1:100000 epinephrine) dental anesthesia
    Intervention Description
    Administration, calculation and adjustment of dental local anesthesia doses.
    Primary Outcome Measure Information:
    Title
    Measuring in (ML) the quantity of dental anesthesia used in each participants group to achieve analgesic effect
    Description
    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.
    Time Frame
    3 months
    Title
    To determine the number of dental anesthesia carpules used for each group participants during dental and oral procedures
    Description
    Among addicted and non-addicted patients, the number of carpules of dental anesthesia necessary for total analgesic effect will be determined.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    To determine the quantity ( mg) of tramadol and the time of consumption ( in months) necessary to cause dental anesthesia failure among addicted patients.
    Description
    As our hypothesis suggested that tramadol addiction cause dental anesthesia failure, we would like to calculate the dose and number of months of tramadol consumption necessary to provok dental anesthesia failure as an addiction complication
    Time Frame
    3 months

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    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.
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohammed Amir Rais, DMD
    Phone
    +213696988763
    Email
    raismohammedamir@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohammed Amir Rais
    Phone
    +213696988763
    Email
    raismohammedamir@gmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24346042
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    15804720
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32467795
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20478804
    Citation
    Fung EY, Giannini PJ. Implications of drug dependence on dental patient management. Gen Dent. 2010 May-Jun;58(3):236-41; quiz 242-3.
    Results Reference
    background

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    Impact of Tramadol Addiction On Dental Anesthesia Success

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