Analgesic Effect of Oral Glucose in Neonates

Makassed General Hospital

Status: Unknown

Conditions: Pain

Treatments: Other: 30% glucose; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04467177

18122019

Details and patient eligibility

About

Background: Male circumcision is one of the oldest and most common operations performed all over the world. It can be performed at different ages, using different surgical techniques, for different religious, cultural and medical reasons. It was thought that the newborn baby does not experience pain because of incompletely developed nervous system. However, it has been shown that neurological system known to be associated with pain transmission and modulation, is intact and functional.

OBJECTIVE: Our objective is to determine if a 30% glucose solution would reduce pain after circumcision compared with normal saline.

STUDY DESIGN: This is a randomized placebo-controlled double-blinded clinical trial.

POPULATION: We will include full term neonates, who will be recruited from the inpatient nursery at Makassed General Hospital over a 1-year period.

OUTCOME MEASURE: The primary outcome is to assess efficacy of 30% glucose on pain measured using the Neonatal Infant Pain Score.

Secondary outcome is to assess effect of 30% glucose oh physiologic parameters

Enrollment: 60 estimated patients

Sex: Male

Ages: 1 to 28 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Estimated gestational age: 37 weeks-42 weeks
• Birth weight: 2500 grams-4000 grams
• Apgar scores a minimum of 7 at 1 and 5 minutes respectively
• Heart rate between 100 and 160 per minutes
• Blood O2 saturation of at least 95%
• No recognized congenital abnormalities

Exclusion criteria

• They were transferred to the neonatal intensive care unit (NICU)
• They required respiratory support

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Glucose group

Experimental group

Description:

Neonates will receive 30% oral glucose

Treatment:

Other: 30% glucose

Placebo group

Placebo Comparator group

Description:

Neonates will receive sterile water

Treatment:

Other: Placebo