The efficacy of sucrose for relieving lumbar puncture pain in neonates of Kamali hospital in Karaj, randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220703055360N1

Enrollment

Registered

2023-02-14

Start date

2023-02-20

Completion date

Unknown

Last updated

2023-03-13

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

Conditions

pain control. Pain, not elsewhere classified

Interventions

Intervention 1: Intervention group: The group that is given 2 cc of oral 25% sucrose. Intervention 2: Control group: The group that is given 2 cc of distilled water.

Eligibility

Sex/Gender

All

Age

1 Days to 28 Days

Inclusion criteria

Inclusion criteria: being term (in neonates) age under 28 days no fever (body temperature under 38 centigrade) no feeding before 30 minutes before studying

Exclusion criteria

Exclusion criteria: having congenital anomalies having metabolic diseases

Design outcomes

Primary

Measure	Time frame
Neonatal infant pain score (NIPS). Timepoint: before, first minute and third minute. Method of measurement: observation of neonate and Measurement of NIPS and physiologic criteria. This criterion includes examining facial changes, crying, breathing pattern, motor activity, and arousal state. Facial changes include two points, if there are loose muscles and a relaxed face, zero points are given, and if there are any of the changes such as contraction of facial muscles, pulling together eyebrows, chin, or jaw, one point is given. The quality of crying is also given three points including zero points in case of no crying, point one in case of brief and intermittent crying, and point two in case of excessive, continuous, loud crying. Breathing status includes zero scores in case of any change in the normal breathing status such as holding the breath, breathing faster than usual, and irregular breathing. condition of upper and lower limbs; Each of them will receive a score of zero in the presence of muscle stiffness and accidental movements of the limbs, and a score of one in the presence of muscle stiffness and rapid bending and straightening movements; and to the state of consciousness; If there is no change in sleeping or waking state, a score of zero is given, and if there is any restlessness, a score of one is given. The physiological criteria (O2 saturation) studied include heart rate, breathing rate, and blood oxygen saturation percentage.	—

Measure

Time frame

Neonatal infant pain score (NIPS). Timepoint: before, first minute and third minute. Method of measurement: observation of neonate and Measurement of NIPS and physiologic criteria. This criterion includes examining facial changes, crying, breathing pattern, motor activity, and arousal state. Facial changes include two points, if there are loose muscles and a relaxed face, zero points are given, and if there are any of the changes such as contraction of facial muscles, pulling together eyebrows, chin, or jaw, one point is given. The quality of crying is also given three points including zero points in case of no crying, point one in case of brief and intermittent crying, and point two in case of excessive, continuous, loud crying. Breathing status includes zero scores in case of any change in the normal breathing status such as holding the breath, breathing faster than usual, and irregular breathing. condition of upper and lower limbs; Each of them will receive a score of zero in the presence of muscle stiffness and accidental movements of the limbs, and a score of one in the presence of muscle stiffness and rapid bending and straightening movements; and to the state of consciousness; If there is no change in sleeping or waking state, a score of zero is given, and if there is any restlessness, a score of one is given. The physiological criteria (O2 saturation) studied include heart rate, breathing rate, and blood oxygen saturation percentage.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Jashni Motlagh

Alborz University of Medical Science

sinamashayekhi13760911@gmail.com+98 26 3419 7000

Outcome results

None listed

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