Study of Tramadol Addiction Impact on Dental Anesthesia Success Among Algerian Males
1 other identifier
interventional
400
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2022
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2022
CompletedFirst Submitted
Initial submission to the registry
June 10, 2022
CompletedFirst Posted
Study publicly available on registry
June 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedJune 16, 2022
June 1, 2022
3 months
June 10, 2022
June 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anesthesia dose
Anesthesia carbols number through which both conc and dose needed in dental intervention in both arms
3 months
Study Arms (2)
Non- Tramadol
ACTIVE COMPARATORthe control group represented by dental patients who are not a tramadol addict
Tramadol
ACTIVE COMPARATORThe study group with patients seeking dental service but also are tramadol addict.
Interventions
Eligibility Criteria
You may qualify if:
- Males
- ≥18 years
- With no comorbid conditions (HTN, Diabetes \& Epilepsy)
- Tramadol addict (regular tramadol user)
You may not qualify if:
- Females
- ˂ 18 years
- With comorbid conditions (HTN, Diabetes \& Epilepsy)
- ≥ 65 years males
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Doaa El-Bohy
Cairo, 11817, Egypt
Future University in egypt
Cairo, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Doaa MS El-Bohy, PhD
FUE
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisstant professor
Study Record Dates
First Submitted
June 10, 2022
First Posted
June 14, 2022
Study Start
May 1, 2022
Primary Completion
August 1, 2022
Study Completion
August 1, 2022
Last Updated
June 16, 2022
Record last verified: 2022-06