Clinical trial NCT05908305: Impact of Tramadol Addiction On Dental Anesthesia Success
Official title: Study of Tramadol Addiction Impact on Dental Anesthesia Succes.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dental Pain and Sensation Disorder
Anesthesia, Local
Addiction, Opioid
Keywords: Tramadol
Addiction
Local Anesthesia
Dentistry
Carpule
Lead sponsor: University of Algiers
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assessing local dental anesthesia success while performing different dental care among Algerian males addicted or not addicted to tramadol.
Primary purpose: SCREENING

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measuring in (ML) the quantity of dental anesthesia used in each participants group to achieve analgesic effect
timeFrame: 3 months
measure: To determine the number of dental anesthesia carpules used for each group participants during dental and oral procedures
timeFrame: 3 months
Secondary outcomes:
measure: To determine the quantity ( mg) of tramadol and the time of consumption ( in months) necessary to cause dental anesthesia failure among addicted patients.
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
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.
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.
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.