Analgesic Effect of Oral Glucose in Neonates

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Makassed General Hospital
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Updated on 16 February 2024
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analgesics
oximetry
nervousness
circumcision

Summary

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

Details
Condition Pain, Pain, Acute Pain Service
Age 1years or below
Treatment Placebo, 30% glucose
Clinical Study IdentifierNCT04467177
SponsorMakassed General Hospital
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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