ORAQIX SUMMARY
Oraqix® (lidocaine and prilocaine periodontal gel,) 2.5%/2.5% is a microemulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature, therefore both local anesthetics exist as liquid oils rather than as crystals. Oraqix® contains poloxamer excipients, which show reversible temperature-dependent gelation. Together with the lidocaine-prilocaine 1:1 mixture, the poloxamers form a low-viscosity fluid system at room temperature and an elastic gel in the periodontal pocket. Oraqix® is administered into periodontal pockets, by means of the supplied special applicator. Gelation occurs at body temperature, followed by release of the local anesthetics, lidocaine and prilocaine. The Oraqix® single-use glass cartridges deliver up to 1.7g(1.7mL) of gel (42.5 mg of lidocaine and 42.5 mg of prilocaine). Prilocaine base and lidocaine base are both relatively hydrophilic amino-amides.
Oraqix® is indicated for adults who require localized anesthesia in periodontal pockets during scaling and/or root planing.
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NEWS HIGHLIGHTS
Published Studies Related to Oraqix (Lidocaine / Prilocaine Periodontal)
Local anesthetic effects of Lidocaine cream: randomized controlled trial using a standardized prick pain. [2011.07.31] Abstract Background: ELA-max (4% Lidocaine) and EMLA cream (Lidocaine-Prilocaine 2.5%) are topicals used for superficial anesthesia. Only few studies have been published on their comparative effectiveness in close-to-practice pain models.
Lidocaine spray administration during transrectal ultrasound guided prostate biopsy modified the discomfort and pain of the procedure: results of a randomized clinical trial. [2010.06] OBJECTIVES: We report the results of a study about the possible benefit of lidocaine spray perineal administration before transrectal ultrasound guided biopsy of the prostate. Many patients frequently report some kind of discomfort and (or) pain during this procedure, that when pain is severe, may be necessary to interrupt... CONCLUSIONS: Pain score results showed that the use of intrarectal lidocaine spray provided significantly better pain control than cream and anaesthetic gel. Our pain score data suggests that lidocaine spray provides efficient patient comfort during prostate biopsy by reducing pain both during probe insertion and insertion of the needle through the prostate gland. The use of lidocaine spray makes an excellent alternative, causing a reduction of anal sphincter tone with better patient compliance and tolerability to the ultrasound probe during biopsies with an optimization in terms of cost-effectiveness of the procedure.
Lidocaine-based topical anesthetic with disinfectant (LidoDin) versus EMLA for venipuncture: a randomized controlled trial. [2009.10] OBJECTIVE: To examine the efficacy and safety of a new topical anesthetic containing a disinfection ingredient (LidoDin cream) in reducing the pain associated with venipuncture by comparing it with the proven eutectic mixture of lidocaine 2.5% and prilocaine 2.5% (EMLA cream)... Future studies are planned to determine, if LidoDin reduces the rate of local skin infection in patients treated with multiple daily subcutaneous injections of medications.
Topical anesthesia for rubber dam clamp placement in sealant placement: comparison of lidocaine/prilocaine gel and benzocaine. [2009.09] PURPOSE: The purpose of this prospective study was to compare the efficacy of Oraqix to benzocaine while placing a rubber dam clamp during sealant placement on children... CONCLUSIONS: Application of Oraqix did not reduce discomfort when compared to benzocaine in this small sample size. Oraqix was more effective than benzocaine in the age group 9 and older. A larger sample size is needed to determine its efficacy in children younger than 9years old.
Comparison between lidocaine-prilocaine cream (EMLA) and mepivacaine infiltration for pain relief during perineal repair after childbirth: a randomized trial. [2009.08] OBJECTIVE: The purpose of this study was to compare the effectiveness of topically applied lidocaine-prilocaine (EMLA) cream with local anesthetic infiltration in the reduction of pain during perineal suturing after childbirth... CONCLUSION: EMLA cream appears to be an effective and satisfactory alternative to local anesthetic infiltration for the relief of pain during perineal repair.
Clinical Trials Related to Oraqix (Lidocaine / Prilocaine Periodontal)
Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation [Completed]
The purpose of this study is to evaluate the effectiveness, safety and tolerability of the
investigational drug, PSD502 in subjects with premature ejaculation (PE) The study drug,
PSD02, is a metered dose (measured dose), topical (applied to the skin surface) anesthetic
(numbing) spray containing a mixture of lidocaine and prilocaine. The study drug will be
applied in a spray to the penis prior to intercourse in order to decrease sensitivity in an
attempt to delay ejaculation.
Evaluation of Analgesia With EMLA and Glucose Oral Solution [Completed]
Emla-Cream as Pain Relief During Pneumococcal Vaccination [Recruiting]
The aim of this intervention study is to compare the efficacy of Emla cream as a pain relief
or no pain relief in connection to the first pneumococcal vaccination at the age of three
months in Child health care.
Primary objective
1. Leads Emla cream as pain relief to children in connection with pneumococcal vaccination at
the age of three months to lower pain scores in the use of FLACC as a pain measurement
instrument?
Pediatric Study to Access Pharmacokinetics and Safety of Oraqix Gel [Completed]
To establish Oraqix is safe when used on adolescent volunteers.
Evaluation of the Analgesy With Emla and/or Nitrous Oxide in Pediatric Patients for Lumbar Puncture [Completed]
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