Impact of Tramadol Addiction On Dental Anesthesia Success

University of Algiers

Status and phase: Not yet enrolling; Phase 4

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05908305

Tramadol Addict Impact On Dent

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Tramadol Addicted Patients

Active Comparator group

Description:

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

Treatment:

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

Non addicted patients

Active Comparator group

Description:

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

Treatment:

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