Study of Tramadol Addiction Impact on Dental Anesthesia Succes.
| Registry | NCT05908305 |
|---|---|
| Status | Unknown |
| Phase | Phase 4 |
| Study type | Interventional; non randomized, parallel, masking: single, screening |
| Enrollment | 300 (Estimated) |
| Sponsor | University of Algiers (Other) |
| Conditions | Dental Pain and Sensation Disorder, Anesthesia, Local, Addiction, Opioid |
| Interventions | articaine@ (4% 1:100000 epinephrine) dental anesthesia (Drug) |
| Dates | start 2023-06-10 (estimated), primary completion 2023-09-29 (estimated), completion 2023-10-15 (estimated), first posted 2023-06-18, last updated 2023-06-18 |
Related Papers Related Patents Related Grants Related Experts
All trials for Dental Pain and Sensation Disorder All trials for Anesthesia, Local All trials of articaine@ (4% 1:100000 epinephrine) dental anesthesia
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Tramadol Addicted Patients | Active comparator | Drug: articaine@ (4% 1:100000 epinephrine) dental anesthesia | It represents the group of tramadol addicted patients seeking dental care that require dental anesthesia. |
| Non addicted patients | Active comparator | Drug: articaine@ (4% 1:100000 epinephrine) dental anesthesia | The group of patients requiring dental care with local anesthesia and who are not addicted to tramadol. |
Sex: Male, ages: 18 Years to 65 Years, 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.