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Impact of Tramadol Addiction On Dental Anesthesia Success

Study of Tramadol Addiction Impact on Dental Anesthesia Succes.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05908305
Enrollment
300
Registered
2023-06-18
Start date
2023-06-10
Completion date
2023-10-15
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Tramadol, Addiction, Local Anesthesia, Dentistry, Carpule

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.

Interventions

DRUGarticaine@ (4% 1:100000 epinephrine) dental anesthesia

Administration, calculation and adjustment of dental local anesthesia doses.

Sponsors

University of Algiers
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Caregiver)

Masking description

Dentists providing dental care participating in the study are masked.

Intervention model description

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

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
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.

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.

Design outcomes

Primary

MeasureTime frameDescription
Measuring in (ML) the quantity of dental anesthesia used in each participants group to achieve analgesic effect3 monthsThe 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 procedures3 monthsAmong addicted and non-addicted patients, the number of carpules of dental anesthesia necessary for total analgesic effect will be determined.

Secondary

MeasureTime frameDescription
To determine the quantity ( mg) of tramadol and the time of consumption ( in months) necessary to cause dental anesthesia failure among addicted patients.3 monthsAs 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

Contacts

Primary ContactMohammed Amir Rais, DMD
raismohammedamir@gmail.com+213696988763
Backup ContactMohammed Amir Rais
raismohammedamir@gmail.com+213696988763

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026