Clinical trial NCT05418504: Study of Tramadol Addiction Impact on Dental Anesthesia Success Among Algerian Males
Official title: Study of Tramadol Addiction Impact on Dental Anesthesia Success Among Algerian Males
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dental Procedure
Keywords: Dental anesthesia
tramadol
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 400
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SCREENING

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Anesthesia dose
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Doaa El-Bohy
city: Cairo
country: Egypt
facility: Future University in egypt
Study officials:
affiliation: FUE
name: Doaa MS El-Bohy, PhD
role: PRINCIPAL_INVESTIGATOR
References: