Impact of Tramadol Addiction On Dental Anesthesia Success

Sponsor

University of Algiers (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05908305

Collaborator

(none)

300

Enrollment

Arms

4.2

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Pain and Sensation Disorder Anesthesia, Local Addiction, Opioid	Drug: articaine@ (4% 1:100000 epinephrine) dental anesthesia	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Care Provider)

Masking Description:

Dentists providing dental care participating in the study are masked.

Primary Purpose:

Screening

Official Title:

Study of Tramadol Addiction Impact on Dental Anesthesia Succes.

Anticipated Study Start Date :

Jun 10, 2023

Anticipated Primary Completion Date :

Sep 29, 2023

Anticipated Study Completion Date :

Oct 15, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Tramadol Addicted Patients

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

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

Administration, calculation and adjustment of dental local anesthesia doses.

Other Names:

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

Active Comparator: Non addicted patients

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

Administration, calculation and adjustment of dental local anesthesia doses.

Other Names:

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

Outcome Measures

Primary Outcome Measures

Measuring in (ML) the quantity of dental anesthesia used in each participants group to achieve analgesic effect [3 months]
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 [3 months]
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. [3 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.