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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"

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201008234618N1
Enrollment
90
Registered
2010-09-09
Start date
2010-04-09
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Diclofenac gel on vein puncture pain severity with vein catheter. Condition 2: EMLA ointment on vein puncture pain severity with vein catheter. Other nonsteroidal anti-inflammatory drugs Local anaesthetics

Interventions

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 con
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 - gra
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 - Ira
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 4

Sponsors

Sediqeh Khalili (personal)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Vein puncture pain severity with vein catheter. Timepoint: 3-5 minutes after vein catheter installation. Method of measurement: Visual analogue scale.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSediqeh Khalili

Mazandaran University of Medical Sciences

khalili@mazums.ac.ir+98 15 1214 4000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026