Impact of Tramadol Addiction On Dental Anesthesia Success

Anesthesia, Local Clinical Trial

Official title:

Study of Tramadol Addiction Impact on Dental Anesthesia Succes.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05908305
• Other study ID #: Tramadol Addict Impact On Dent
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 10, 2023
• Est. completion date: October 15, 2023

Study information

• Verified date: June 2023
• Source: University of Algiers
• Contact: Mohammed Amir Rais, DMD
• Phone: +213696988763
• Email: raismohammedamir[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim is to investigate and to find a correlation between tramadol addiction misuse among Algerian males and Dental Local Anesthesia success while performing dental care and oral surgeries.

Description:

Local anesthesia is by far the most important part of pain control in dentistry, it is the cornerstone that makes many dental procedures possible, not only for the patient but also for the dentist and dental hygienists. Since the pain and the dentist are almost synonymous for the patient, this makes dental anesthesia the most widely administered drugs in the dental clinics. Hence, the failure of local anesthesia in oral medicine presents an undesirable outcome both for the patient and for the practitioner. The intraoperative pain being prevented by the administration of a local anesthesia must be followed by the management of the postoperative pain which can be often intense and thus requiring drugs administration. These drugs could be nonopioid or opioid analgesics which are also frequently used in general medicine as Tramadol. Tramadol is 2-(dimethyl amino)-methyl)-1-(3'-methoxyphenyl) cyclohexanol hydrochloride. It is 4-phenyl-piperidine analogue of the opioid drug codeine. It is generally well tolerated with few and rare side effects. Moreover, comparative studies have mostly shown that Tramadol is more effective than NSAIDs for post operative pain control. However, its misuse is increasingly growing and has become obvious in Algeria. Tramadol addiction has become very frequent, and its unjustified use is expanding. This might be attributed to the fragility of the health system and the replacement of the qualified pharmacists by non-qualified helpers or assistants.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: October 15, 2023
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Males
• =18 years old <65
• Without comorbid conditions (Hypertension, diabetes, Asthma etc..)
• Tramadol addicted (regular tramadol user)
• Only tramadol addicted, if any other drugs are regularly consumed, the patient is excluded.

Exclusion Criteria:

• Females
• ? 18 years old
• With comorbid conditions (HTN, diabetes, epilepsy etc..)
• = 65 years old men.
• Not addicted to tramadol or addicted to other drugs with it.

Related Conditions & MeSH terms

• Addiction, Opioid
• Anesthesia, Local
• Behavior, Addictive
• Dental Pain and Sensation Disorder
• Opioid-Related Disorders
• Sensation Disorders

Intervention

Drug:
• articaine@ (4% 1:100000 epinephrine) dental anesthesia
Administration, calculation and adjustment of dental local anesthesia doses.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Algiers

References & Publications (4)

Carnaval TG, Sampaio RM, Lanfredi CB, Borsatti MA, Adde CA. Effects of opioids on local anesthesia in the rat: a codeine and tramadol study. Braz Oral Res. 2013 Nov-Dec;27(6):455-62. doi: 10.1590/S1806-83242013000600003. — View Citation

Fung EY, Giannini PJ. Implications of drug dependence on dental patient management. Gen Dent. 2010 May-Jun;58(3):236-41; quiz 242-3. — View Citation

Guven M, Mert T, Gunay I. Effects of tramadol on nerve action potentials in rat: comparisons with benzocaine and lidocaine. Int J Neurosci. 2005 Mar;115(3):339-49. doi: 10.1080/00207450590520948. — View Citation

Premnath S, Alalshaikh G, Alfotawi R, Philip M. The Association Between Coffee Consumption and Local Anesthesia Failure: Social Beliefs and Scientific Evidence. Cureus. 2020 Apr 24;12(4):e7820. doi: 10.7759/cureus.7820. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring in (ML) the quantity of dental anesthesia used in each participants group to achieve analgesic effect	The quantity (ml) of dental anesthesia used to perform dental and oral surgery procedure among tramadol addicted and non-addicted patients will be mesured to investigate the difference.	3 months
Primary	To determine the number of dental anesthesia carpules used for each group participants during dental and oral procedures	Among addicted and non-addicted patients, the number of carpules of dental anesthesia necessary for total analgesic effect will be determined.	3 months
Secondary	To determine the quantity ( mg) of tramadol and the time of consumption ( in months) necessary to cause dental anesthesia failure among addicted patients.	As our hypothesis suggested that tramadol addiction cause dental anesthesia failure, we would like to calculate the dose and number of months of tramadol consumption necessary to provok dental anesthesia failure as an addiction complication	3 months