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IRCT201008234618N1 IRCT 2010-09-09 Sediqeh Khalili (personal) Clinical Trial "Assessment of the effect of Diclofenac gel and EMLA" ointment" Clinical Trial "Assessment of the effect of Diclofenac gel and EMLA ointment on vein puncture pain severity with vein catheter in patient undergoing cesarean section" 2010-04-09 anticipated 90 Complete https://irct.ir/trial/4955 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. 3 Condition 1: Diclofenac gel on vein puncture pain severity with vein catheter. Condition 2: EMLA ointment on vein puncture pain severity with vein catheter. Intervention 1: Researcher put the size of 2 g of EMLA ointment (EMLA ointment 5% mixture of lidocaine 2.5% and 2.5% prilocaine Manufactured by Tehran Chemie Pharmaceutical Co. Tehran - Iran, that containing 30 - gram tubes with confirmation Ministry of Health) in the level of the 2.5 × 4 cm EMLA group ointment on the behind at the left hand, before an hour catheter insertion and covered the area with transparent dressing. Intervention 2: Researcher put the size of 100 mg of diclofenac gel (diclofenac gel 1% Each 100 grams contains: diclofenac Diethyl ammonium equivalent to diclofenac sodium 1 g, Manufactured by Behvzan Co. Rasht - Iran that containing 60 grams tubes with confirmation Ministry of Health) in the level of the 1.9 × 3.8 cm diclofenac group gel on the behind at the left hand, before an hour catheter insertion and covered the area with transparent dressing. Intervention 3: Researcher put the size of 100 mg of Vaseline ointment (Vaseline ointment compounds that liquid paraffin and glycerin, Lanolin and Fragrance free, Manufactured by Pars Hayan Co. Iran that containing 45 grams tubes with confirmation Ministry of Health) in the level of the 1.9 × 3.8 cm placed group on the behind at the left hand, before an hour catheter insertion and covered the area with transparent dressing.
public Sediqeh Khalili
Joybar Three-way, Imam Square
Sari Iran (Islamic Republic of) 4815733971 +98 15 1214 4000 khalili@mazums.ac.ir Mazandaran University of Medical Sciences scientific Sediqeh Khalili
Shariati, Zargndeh
Tehran Iran (Islamic Republic of) 19168 +98 21220066607 shomia@ymail.com Islamic Azad University, Tehran Medical Iran (Islamic Republic of) Study Entry Requirements: aged 18 to 40 years; don’t have any defect in terms of mental and visual and verbal ability; Patients who doesn’t have any sensitivity to local anaesthetics or allergy to NSAIDs; haven’t used analgesics during the previous 24 hours; don’t have Favism, methemoglobin, liver and kidney disease, asthma, skin allergies, skin dermatitis, wound in the area assigned for intervention, active gastrointestinal bleeding, allergies to topical anaesthetics and non steroidal anti-inflammatory drugs included in this study. Study Exclusion: if the insertion vein catheter be unsuccessful in the first attempt or the caesarean section become an emergency operation. 18 years 40 years Female Y45.3 Y48.3 Other nonsteroidal anti-inflammatory drugs Local anaesthetics Prevention Prevention Prevention Researcher put the size of 2 g of EMLA ointment (EMLA ointment 5% mixture of lidocaine 2.5% and 2.5% prilocaine Manufactured by Tehran Chemie Pharmaceutical Co. Tehran - Iran, that containing 30 - gram tubes with confirmation Ministry of Health) in the level of the 2.5 × 4 cm EMLA group ointment on the behind at the left hand, before an hour catheter insertion and covered the area with transparent dressing. Researcher put the size of 100 mg of diclofenac gel (diclofenac gel 1% Each 100 grams contains: diclofenac Diethyl ammonium equivalent to diclofenac sodium 1 g, Manufactured by Behvzan Co. Rasht - Iran that containing 60 grams tubes with confirmation Ministry of Health) in the level of the 1.9 × 3.8 cm diclofenac group gel on the behind at the left hand, before an hour catheter insertion and covered the area with transparent dressing. Researcher put the size of 100 mg of Vaseline ointment (Vaseline ointment compounds that liquid paraffin and glycerin, Lanolin and Fragrance free, Manufactured by Pars Hayan Co. Iran that containing 45 grams tubes with confirmation Ministry of Health) in the level of the 1.9 × 3.8 cm placed group on the behind at the left hand, before an hour catheter insertion and covered the area with transparent dressing. Vein puncture pain severity with vein catheter. Timepoint: 3-5 minutes after vein catheter installation. Method of measurement: Visual analogue scale. Short-term effects of topical drugs diclofenac gel, anesthetic cream EMLA and vaseline cream. Timepoint: application local medications later One hour. Method of measurement: Checklist of short-term effects of topical drugs. Sediqeh Khalili (personal) Approved 2010-04-29 Islamic Azad University, Medical Sciences Tehran Shariaty, Zargande Tehran Iran (Islamic Republic of)