Evaluation of nitroglycerine and lidocaine ointment on the pain caused by catheterization in neonates

Investigation of the effect of 2% nitroglycerin ointment - 2% lidocaine on the pain control due to intravenous catheter in infants; randomized double-blind clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190810044500N19

Enrollment

Registered

2021-08-22

Start date

2021-08-23

Completion date

Unknown

Last updated

2021-08-30

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

Conditions

Measurement of pain during catheterization in infants.

Interventions

Intervention 1: Intervention group: Topical nitroglycerin ointment 2% - lidocaine 2%, one gram with an area of one square centimeter, on the infant venous site, apply and then wait for 10 minutes and

Eligibility

Sex/Gender

All

Age

1 Days to 1 Months

Inclusion criteria

Inclusion criteria: Infants with non-complicated cesarean delivery or normal birth gestational age greater than 34 weeks and postnatal age less than 4 weeks need to intravenous catheterization

Exclusion criteria

Exclusion criteria: Parents' dissatisfaction with their baby's participation in the study

Design outcomes

Primary

Measure	Time frame
Pain score of catheterization. Timepoint: After catheterization. Method of measurement: PIPP Score.;How long the baby cries after catheterization. Timepoint: After catheterization. Method of measurement: The duration of the baby's crying is recorded in seconds.;How long it takes for the baby to start crying. Timepoint: during catheterization. Method of measurement: The time it takes for a baby to start crying is recorded in seconds.;How long the procedure lasts. Timepoint: during catheterization. Method of measurement: The duration of the procedure is recorded in seconds.	—

Measure

Time frame

Pain score of catheterization. Timepoint: After catheterization. Method of measurement: PIPP Score.;How long the baby cries after catheterization. Timepoint: After catheterization. Method of measurement: The duration of the baby's crying is recorded in seconds.;How long it takes for the baby to start crying. Timepoint: during catheterization. Method of measurement: The time it takes for a baby to start crying is recorded in seconds.;How long the procedure lasts. Timepoint: during catheterization. Method of measurement: The duration of the procedure is recorded in seconds.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Saghafi

Yazd University of Medical Sciences

F.saghafi@ssu.ac.ir+98 35 3419 3820

Outcome results

None listed

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