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

Future University in Egypt

Status and phase: Enrolling; Phase 4

Conditions: Dental Procedure

Treatments: Drug: Dental anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT05418504

REC-FOPFUE-16/119

Details and patient eligibility

About

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

Full description

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

Enrollment: 400 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Non- Tramadol

Active Comparator group

Description:

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

Treatment:

Drug: Dental anesthesia

Tramadol

Active Comparator group

Description:

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

Treatment:

Drug: Dental anesthesia