Study of Tramadol Addiction Impact on Dental Anesthesia Success Among Algerian Males
Primary Purpose
Dental Procedure
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Dental anesthesia
Sponsored by
About this trial
This is an interventional screening trial for Dental Procedure focused on measuring Dental anesthesia, 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
Sites / Locations
- Doaa El-BohyRecruiting
- Future University in egyptRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Non- Tramadol
Tramadol
Arm Description
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.
Outcomes
Primary Outcome Measures
Anesthesia dose
Anesthesia carbols number through which both conc and dose needed in dental intervention in both arms
Secondary Outcome Measures
Full Information
NCT ID
NCT05418504
First Posted
June 10, 2022
Last Updated
June 14, 2022
Sponsor
Future University in Egypt
1. Study Identification
Unique Protocol Identification Number
NCT05418504
Brief Title
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Future University in Egypt
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Procedure
Keywords
Dental anesthesia, tramadol
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non- Tramadol
Arm Type
Active Comparator
Arm Description
the control group represented by dental patients who are not a tramadol addict
Arm Title
Tramadol
Arm Type
Active Comparator
Arm Description
The study group with patients seeking dental service but also are tramadol addict.
Intervention Type
Drug
Intervention Name(s)
Dental anesthesia
Intervention Description
Dental anesthesia, used to do any dental procedure
Primary Outcome Measure Information:
Title
Anesthesia dose
Description
Anesthesia carbols number through which both conc and dose needed in dental intervention in both arms
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doaa MS El-Bohy, PhD
Phone
01224474013
Email
delbohy@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Heba A ElRamly, PhD
Phone
01002134523
Email
hramly146@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doaa MS El-Bohy, PhD
Organizational Affiliation
FUE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Doaa El-Bohy
City
Cairo
ZIP/Postal Code
11817
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doaa MS El-Bohy, PhD
Phone
01224474013
Email
delbohy@gmail.com
Facility Name
Future University in egypt
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doaa El-Bohy, PhD
12. IPD Sharing Statement
Learn more about this trial
Study of Tramadol Addiction Impact on Dental Anesthesia Success Among Algerian Males
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