Impact of Tramadol Addiction On Dental Anesthesia Success

June 8, 2023 updated by: Mohammed Amir Rais, University of Algiers

Study of Tramadol Addiction Impact on Dental Anesthesia Succes.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

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
Time Frame: 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.
3 months
To determine the number of dental anesthesia carpules used for each group participants during dental and oral procedures
Time Frame: 3 months
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.
Time Frame: 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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Algiers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 10, 2023

Primary Completion (Estimated)

September 29, 2023

Study Completion (Estimated)

October 15, 2023

Study Registration Dates

First Submitted

December 4, 2022

First Submitted That Met QC Criteria

June 8, 2023

First Posted (Estimated)

June 16, 2023

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tramadol Addict Impact On Dent

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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