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The effect of EMLA and massage on the pain and anxiety of children

Comparison of the effect of EMLA and massage on the pain and anxiety caused by intravenous insertion in hospitalized children of 3-6 years old

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190201042579N1
Enrollment
140
Registered
2019-03-28
Start date
2016-08-23
Completion date
Unknown
Last updated
2019-04-23

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

Conditions

Condition 1: Children who needed surgery and intravenus line insertion to repair stenosis in the esophagus. Condition 2: Children with inguinal hernia who needed surgery did not have pain during the procedure. Condition 3: Children with inguinal hernia who needed surgery and did not have pain during the procedure. Condition 4: Children who needed intravenus cannula insertion for surgery to remove Obstruction of gallbladder. Esophageal obstruction Inguinal hernia Umbilical hernia Obstruction

Interventions

Intervention 1: First Intervention group: First intervention group: EMLA cream 1.5 grams of EMLA cream 5%(One gram containing 25 mg of lidocaine and 25 mg of perlocaine) was used, which was done 60 mi

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 6 Years

Inclusion criteria

Inclusion criteria: Age of 6 to 3 years, having no pain before the start of venipuncture, having complete consciousness and physiological stability, lack of mental retardation lack of analgesic , sedative, corticosteroid and relaxant medication.

Exclusion criteria

Exclusion criteria: The occurrence of any phenomenon violates the inclusion criteria to the study Failure to insert the intravenous line with an cannula insertion into the skin and the need for re-effort,

Design outcomes

Primary

MeasureTime frame
Behavioral changes related to Pain. Timepoint: behavioral changes related to Pain were evaluated Immediately after the cannula insertion of the skin. Method of measurement: behavioral changes related to pain with the wong baker face and FLACC Pain Rating Scale.;Changes of the amount of anxiety. Timepoint: Before and After of Intravenus Line Insertion. Method of measurement: visual anxiety scale.;Changes in heart rate related to pain. Timepoint: measurement of heart rate before and immediately after cannula insertion. Method of measurement: heart rate were measured with calibrate pulse oximetry that its model is novametrix.;Changes in arterial oxygen saturation percentage related to pain. Timepoint: measurement of arterial oxygen saturation percentage before and immediately after cannula insertion. Method of measurement: arterial oxygen saturation percentage were measured with calibrate pulse oximetry that its model is novametrix.;Changes in respiratory rate related to pain. Timepoint: measurement of respiratory rate before and immediately after cannula insertion. Method of measurement: Respiratory rate were measured by counting in a one minute by nurse.;Changes in blood pressure related to pain. Timepoint: measurement of blood pressure before and immediately after cannula insertion. Method of measurement: blood pressure were measured by the calibrate mercury barometer appropriate to the child's arm size (Model: fmt).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHanieh Neshat

Tabriz University of Medical Sciences

haie.neshat@gmail.com+98 41 3477 7283

Outcome results

None listed

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