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

Sponsor
Future University in Egypt (Other)
Overall Status
Recruiting
CT.gov ID
NCT05418504
Collaborator
(none)
400
Enrollment
2
Locations
2
Arms
3
Anticipated Duration (Months)
200
Patients Per Site
66.2
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Dental anesthesia
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
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.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)
Primary Purpose:
Screening
Official Title:
Study of Tramadol Addiction Impact on Dental Anesthesia Success Among Algerian Males
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Anesthesia dose [3 months]

    Anesthesia carbols number through which both conc and dose needed in dental intervention in both arms

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Doaa El-Bohy Cairo Egypt 11817
2 Future University in egypt Cairo Egypt

Sponsors and Collaborators

  • Future University in Egypt

Investigators

  • Principal Investigator: Doaa MS El-Bohy, PhD, FUE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Doaa Mohamed Salah ElDin Diab ELBohy, Assisstant professor, Future University in Egypt
ClinicalTrials.gov Identifier:
NCT05418504
Other Study ID Numbers:
  • REC-FOPFUE-16/119
First Posted:
Jun 14, 2022
Last Update Posted:
Jun 16, 2022
Last Verified:
Jun 1, 2022
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
Keywords provided by Doaa Mohamed Salah ElDin Diab ELBohy, Assisstant professor, Future University in Egypt
Dental anesthesia
tramadol
Additional relevant MeSH terms:
Behavior, Addictive
Anesthetics

Study Results

No Results Posted as of Jun 16, 2022