Impact of Tramadol Addiction On Dental Anesthesia Success

NCT ID: NCT05908305

Last Updated: 2023-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-10

Study Completion Date

2023-10-15

Brief Summary

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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

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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.

Conditions

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Dental Pain and Sensation Disorder Anesthesia, Local Addiction, Opioid

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

SCREENING

Blinding Strategy

SINGLE

Caregivers
Dentists providing dental care participating in the study are masked.

Study Groups

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Tramadol Addicted Patients

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Administration, calculation and adjustment of dental local anesthesia doses.

Non addicted patients

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Administration, calculation and adjustment of dental local anesthesia doses.

Interventions

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

Administration, calculation and adjustment of dental local anesthesia doses.

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Algiers

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Amir Rais

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mohammed Amir Rais, DMD

Role: CONTACT

+213696988763

Mohammed Amir Rais

Role: CONTACT

+213696988763

References

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Carnaval TG, Sampaio RM, Lanfredi CB, Borsatti MA, Adde CA. Effects of opioids on local anesthesia in the rat: a codeine and tramadol study. Braz Oral Res. 2013 Nov-Dec;27(6):455-62. doi: 10.1590/S1806-83242013000600003.

Reference Type BACKGROUND
PMID: 24346042 (View on PubMed)

Guven M, Mert T, Gunay I. Effects of tramadol on nerve action potentials in rat: comparisons with benzocaine and lidocaine. Int J Neurosci. 2005 Mar;115(3):339-49. doi: 10.1080/00207450590520948.

Reference Type BACKGROUND
PMID: 15804720 (View on PubMed)

Premnath S, Alalshaikh G, Alfotawi R, Philip M. The Association Between Coffee Consumption and Local Anesthesia Failure: Social Beliefs and Scientific Evidence. Cureus. 2020 Apr 24;12(4):e7820. doi: 10.7759/cureus.7820.

Reference Type BACKGROUND
PMID: 32467795 (View on PubMed)

Fung EY, Giannini PJ. Implications of drug dependence on dental patient management. Gen Dent. 2010 May-Jun;58(3):236-41; quiz 242-3.

Reference Type BACKGROUND
PMID: 20478804 (View on PubMed)

Other Identifiers

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Tramadol Addict Impact On Dent

Identifier Type: -

Identifier Source: org_study_id

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