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

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

Study Overview

• Status: Recruiting
• Conditions: Dental Procedure
• Intervention / Treatment: Drug: Dental anesthesia

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Doaa MS El-Bohy, PhD; Phone Number: 01224474013; Email: delbohy@gmail.com
• Study Contact Backup: Name: Heba A ElRamly, PhD; Phone Number: 01002134523; Email: hramly146@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11817
    • Recruiting
    • Doaa El-Bohy
    • Contact: Doaa MS El-Bohy, PhD; Phone Number: 01224474013; Email: delbohy@gmail.com
  • Cairo, Egypt
    • Recruiting
    • Future University in Egypt
    • Contact: Doaa El-Bohy, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non- Tramadol; the control group represented by dental patients who are not a tramadol addict	Drug: Dental anesthesia; Dental anesthesia, used to do any dental procedure
Active Comparator: Tramadol; The study group with patients seeking dental service but also are tramadol addict.	Drug: Dental anesthesia; Dental anesthesia, used to do any dental procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anesthesia dose	Anesthesia carbols number through which both conc and dose needed in dental intervention in both arms	3 months

Collaborators and Investigators

• Sponsor: Future University in Egypt
• Investigators: Principal Investigator: Doaa MS El-Bohy, PhD, FUE

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Dental anesthesia; tramadol
• Additional Relevant MeSH Terms: Compulsive Behavior; Impulsive Behavior; Behavior, Addictive; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: REC-FOPFUE-16/119

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No