A Phase 4 interventional study of articaine@ (4% 1:100000 epinephrine) dental anesthesia in Dental Pain and Sensation Disorder, Anesthesia, Local and Addiction, Opioid, sponsored by University of Algiers. Not yet recruiting. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-18.
Sponsored by University of Algiers · Phase 4, Interventional, and Screening
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.
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.
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This study's planned enrollment of 300 is above the median of 84 across 123 interventional studies indexed under Toothache.
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Exclusion Criteria:
It represents the group of tramadol addicted patients seeking dental care that require dental anesthesia.
Drug: articaine@ (4% 1:100000 epinephrine) dental anesthesia
The group of patients requiring dental care with local anesthesia and who are not addicted to tramadol.
Drug: articaine@ (4% 1:100000 epinephrine) dental anesthesia
Administration, calculation and adjustment of dental local anesthesia doses.
Also known as: mepivacaine@ (2%@ 1:100000 epinephrine) dental anesthesia
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.
Time frame: 3 months
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.
Time frame: 3 months
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
Time frame: 3 months
No study locations are listed for this record.
Start is estimated for Jun 2023; primary completion for Sep 2023, 3 months later.
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This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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University of Algiers