Impact of Tramadol Addiction On Dental Anesthesia Success

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study of Tramadol Addiction Impact on Dental Anesthesia Succes.

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

Intervention / Treatment
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* Drug: articaine@ (4% 1:100000 epinephrine) dental anesthesia


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Assessing local dental anesthesia success while performing different dental care among Algerian males addicted or not addicted to tramadol.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tramadol Addicted Patients<br>It represents the group of tramadol addicted patients seeking dental care that require dental anesthesia. | Drug: articaine@ (4% 1:100000 epinephrine) dental anesthesia<br>* Administration, calculation and adjustment of dental local anesthesia doses.<br>* Other names: mepivacaine@ (2%@ 1:100000 epinephrine) dental anesthesia;|
| Active Comparator: Non addicted patients<br>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<br>* Administration, calculation and adjustment of dental local anesthesia doses.<br>* Other names: mepivacaine@ (2%@ 1:100000 epinephrine) dental anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tramadol, Addiction, Local Anesthesia, Dentistry, Carpule