Study of Tramadol Addiction Impact on Dental Anesthesia Success Among Algerian Males

NCT ID: NCT05418504

Last Updated: 2022-06-16

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

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2022-08-01

Brief Summary

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Dental anesthesia is considered by far one of the main procedures in dentistry; the performance of a good dental anesthesia with a correct technique is paramount in controlling pain, facilitating the work of the dentist and gaining the confidence and cooperation of the patient

Tramadol is an FDA-approved medication for pain relief indicated mainly for moderate to severe pain, it is an opioid with 6 hours Half-Life and different dosages as 50mg, 100mg, 200mg and 300mg. Due to possible abuse and addiction potential, limitations to its use should be for pain that is refractive to other pain medication, such as non-opioid pain medication, unfortunately, the almost non-existent of censorship in Algeria and the disorderly framing made the obtain of tramadol as a medicine very easy which has led to a very alarming abuse of this drug

Detailed Description

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Tramadol is an FDA-approved medication for pain relief indicated mainly for moderate to severe pain, it is an opioid with 6 hours Half-Life and different dosages as 50mg, 100mg, 200mg and 300mg. Due to possible abuse and addiction potential, limitations to its use should be for pain that is refractive to other pain medication, such as non-opioid pain medication, unfortunately, the almost non-existent of censorship in Algeria and the disorderly framing made the obtain of tramadol as a medicine very easy which has led to a very alarming abuse of this drug Meanwhile, apart from the systemic manifestations resulting from the abusive consumption of tramadol, it has become very clear that this opioid has a negative impact on the rapid and sufficient analgesic effect of dental anesthesia, it has been noticed that the anesthesia does not hold easily and the number of cartridges needed is increased, and therefore, a very particular attention must be attributed to the organization and control of its obtaining in order to limit its addiction in young people, an improvement of the care of patients must be offered according to the parameters necessary in the case of an addiction to tramadol

Conditions

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Dental Procedure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The recruited participants will then be divided into 2 groups the control group represented by dental patients who are not a tramadol addict \& The study group with patients seeking dental service but also are tramadol addict.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Non- Tramadol

the control group represented by dental patients who are not a tramadol addict

Group Type ACTIVE_COMPARATOR

Dental anesthesia

Intervention Type DRUG

Dental anesthesia, used to do any dental procedure

Tramadol

The study group with patients seeking dental service but also are tramadol addict.

Group Type ACTIVE_COMPARATOR

Dental anesthesia

Intervention Type DRUG

Dental anesthesia, used to do any dental procedure

Interventions

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Dental anesthesia

Dental anesthesia, used to do any dental procedure

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males
* ≥18 years
* With no comorbid conditions (HTN, Diabetes \& Epilepsy)
* Tramadol addict (regular tramadol user)

Exclusion Criteria

* Females
* ˂ 18 years
* With comorbid conditions (HTN, Diabetes \& Epilepsy)
* ≥ 65 years males
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Future University in Egypt

OTHER

Sponsor Role lead

Responsible Party

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Doaa Mohamed Salah ElDin Diab ELBohy

Assisstant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Doaa MS El-Bohy, PhD

Role: PRINCIPAL_INVESTIGATOR

FUE

Locations

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Doaa El-Bohy

Cairo, , Egypt

Site Status RECRUITING

Future University in egypt

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Doaa MS El-Bohy, PhD

Role: CONTACT

01224474013

Heba A ElRamly, PhD

Role: CONTACT

01002134523

Facility Contacts

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Doaa MS El-Bohy, PhD

Role: primary

01224474013

Doaa El-Bohy, PhD

Role: primary

Other Identifiers

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REC-FOPFUE-16/119

Identifier Type: -

Identifier Source: org_study_id

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