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

Phase 4

• Conditions: Dental Procedure
• Interventions: Drug: Dental anesthesia

• Registration Number: NCT05418504
• Lead Sponsor: Future University in Egypt

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

Study Timeline

• Study Start: 2022-05-01
• Status Verified: 2022-06
• Study First Submitted: 2022-06-10
• Study First Submitted QC: 2022-06-10
• Study First Posted: 2022-06-14
• Last Update Submitted: 2022-06-14
• Last Update Posted: 2022-06-16
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tramadol	Dental anesthesia	The study group with patients seeking dental service but also are tramadol addict.
Non- Tramadol	Dental anesthesia	the control group represented by dental patients who are not a tramadol addict

Primary Outcome Measures

Name	Time	Method
Anesthesia dose	3 months	Anesthesia carbols number through which both conc and dose needed in dental intervention in both arms

Trial Locations

Locations (2)

Future University in egypt; 🇪🇬 Cairo, Egypt

Doaa El-Bohy; 🇪🇬 Cairo, Egypt