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Analgesic Effect of Oral Glucose in Neonates

NCT04467177 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-07-10

No results posted yet for this study

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

Conditions

Interventions

OTHER

30% glucose

Male neonates will receive 2 ml of 30% glucose two minutes prior to circumcision

OTHER

Placebo

Male neonates will receive 2 ml of sterile water two minutes prior to circumcision

Sponsors & Collaborators

  • Makassed General Hospital

    lead OTHER

Principal Investigators

  • Amal Naous, MD · Makassed General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Lebanon

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04467177 on ClinicalTrials.gov