ORAQIX SUMMARY
oraqix®
(lidocaine and prilocaine periodontal gel) 2.5% / 2.5%
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)
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.
The influence of a eutectic mixture of lidocaine and prilocaine on minor surgical procedures: a randomized controlled double-blind trial. [2009.06]
BACKGROUND: A eutectic mixture of lidocaine and prilocaine (EMLA) has been shown to be effective in reducing pain from needle sticks, including those associated with blood sampling and intravenous insertion. OBJECTIVE: To evaluate the effectiveness of EMLA cream applied before needle puncture for local anesthetic administration before minor surgical procedures in this double-blind, randomized, controlled, parallel-group study... CONCLUSION: EMLA effectively reduces the preprocedural needle-stick pain and procedural pain associated with minor surgical procedures.
A comparison between EMLA cream application versus lidocaine infiltration for postoperative analgesia after inguinal herniotomy in children. [2009.03]
BACKGROUND: EMLA cream (eutectic mixture of local anesthetics) has been shown to penetrate intact skin and provide analgesia of superficial layers. There are no studies on the effects of topical application of EMLA cream for postoperative pain relief after inguinal hernia repair. OBJECTIVE:: This randomized, double-blind, placebo-controlled study compared the efficacy of topical application of 5% EMLA cream before surgery, with wound infiltration with 1% lidocaine for postoperative analgesia in children... CONCLUSION: Topical application of EMLA (5%) provides postoperative analgesia comparable to infiltration with 1% lidocaine after inguinal hernia repair in children.
Combination of perianal-intrarectal lidocaine-prilocaine cream and periprostatic nerve block for pain control during transrectal ultrasound guided prostate biopsy: a randomized, controlled trial. [2009.02]
PURPOSE: To our knowledge the optimal analgesia during prostate biopsy remains undetermined. We tested the efficacy and safety of combined perianal-intrarectal lidocaine-prilocaine cream and periprostatic nerve block during transrectal ultrasound guided prostate biopsy... CONCLUSIONS: Our findings suggest that the combination of perianal-intrarectal lidocaine-prilocaine cream and periprostatic nerve block provides better pain control than the 2 modalities alone during the sampling part of transrectal ultrasound guided prostate biopsy with no increase in the complication rate. The magnitude of this effect is higher in younger men, men with a larger prostate and men with lower anorectal compliance.
Is only perianal anesthesia with lidocaine-prilocaine cream sufficient to decrease the pain during transrectal ultrasound-guided prostate biopsy? A prospective randomized study. [2009]
AIMS: To determine the optimal place to apply the local anesthetic agent and to investigate the efficacy of lidocaine-prilocaine cream on the perianal and intrarectal region during prostate biopsy... CONCLUSIONS: Perianal anesthesia with lidocaine-prilocaine cream may solely be sufficient to decrease the pain during prostate biopsy. Copyright 2009 S. Karger AG, Basel.
Clinical Trials Related to Oraqix (Lidocaine / Prilocaine Periodontal)
Study of Fentanyl-Propofol-EMLA of L.M.X4 Technique for Bone Marrow Aspiration [Active, not recruiting]
St. Jude Children's Research Hospital is studying the best ways to prevent pain during and
after procedures such as bone marrow aspiration and lumbar puncture with intrathecal (in the
spinal fluid) chemotherapy. Researchers will study the effectiveness of combining anesthetics
(medicines that help people sleep) and analgesics (medicines that relieve pain). Researchers
believe that a combination of fentanyl (analgesic) and propofol (anesthetic), along with
applying the skin-numbing-cream EMLA or L. M.X4™ on the area where the procedure is performed,
will provide better pain control.
Each patient enrolled on this study will have three different anesthetic combinations for
three different procedures, in order to determine which combination worked best for each
child.
Evaluation of Analgesia With EMLA and Glucose Oral Solution in Preterm Neonates During Arterial Puncture and PICC Installation [Recruiting]
Improvement of Sensibility in the Foot in Diabetic Patients Induced by EMLA-application to the Lower Leg [Recruiting]
Sensory input from the foot as well as all other body parts results in activation of sensory
cortex.
It is well known that the cortical body map is experienced-dependant and can rapidly change
in response to changes in activity and sensory input from the periphery [10-12]. Increased
activity and sensory input from the hand results in expansion of the cortical hand
representation [13-15], while decreased sensory input, for instance by anaesthesia,
amputation or nerve injury, results in shrinkage of the cortical hand representation
[16-21]. Due to the constant ongoing "cortical competition" between body parts the adjacent
cortical areas expand and take over the silent area, deprived of sensory input.
The investigators have recently described striking examples of such rapid cortical
re-organisations induced by selective cutaneous anaesthesia of the forearm: application of
EMLA cream to the volar aspect of the forearm results in improved sensory functions of the
hand [18] linked to expansion of the hand representational area in sensory cortex . In
analogy, EMLA application to the lower leg in healthy controls results in improved sensory
functions in the sole of the foot linked to expansion of the foot representational area in
sensory cortex.
To test the hypothesis that EMLA application to the lower leg of diabetic patients will
result in improved sensory functions in the sole of the foot as well as expansion of the
foot representation in sensory cortex. The investigators hypothesize that repeated
applications of EMLA will result in a long lasting sensibility improvement.
Randomised Trial of Eutectic Mixture of Local Anaesthetics Cream and Oral Sucrose Solution for Venepuncture [Not yet recruiting]
This randomized bicentric trial will investigate the efficacy of topical EMLA cream with
oral sucrose solution compared to oral sucrose solution alone before venepuncture in preterm
infants.
The Efficacy of EMLA Cream vs. Synera Patch for Pain Reduction During Venipuncture in Children [Recruiting]
The objective of this study is to compare the efficacy of the Synera patch applied for 20
minutes with the efficacy of EMLA Cream applied for 60 minutes in reducing pain associated
with venipunctures in children.
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