Analgesic Effect of Oral Glucose in Neonates

NCT04467177 | Unknown

• 1 other identifier: 18122019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Pain

Outcome Measures

Primary Outcomes (1)

• Pain score

  Pain response will be assessed utilizing the Neonatal Infant Pain Scale. The total pain score ranges from 0 to 10. Scores less than or equal to 3 indicate no pain while scores greater than 3 indicate pain.

  Pain will be assessed 1 minute before the procedure and during the procedure

Secondary Outcomes (3)

• Heart rate

  2 minutes before the procedure, during the procedure and one minute after the procedure

• Respiratory rate

  2 minutes before the procedure, during the procedure and one minute after the procedure

• Oxygen saturation

  2 minutes before the procedure, during the procedure and one minute after the procedure

Study Arms (2)

Glucose group

EXPERIMENTAL

Neonates will receive 30% oral glucose

Other: 30% glucose

Placebo group

PLACEBO COMPARATOR

Neonates will receive sterile water

Other: Placebo

Interventions

30% glucose OTHER

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

Glucose group

Placebo OTHER

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

Placebo group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Glucose

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Amal Naous, MD

  Makassed General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amal Naous, MD

CONTACT

+9611636000; amalnaous@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrician

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 10, 2020
• Study Start: July 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 10, 2020

Record last verified: 2020-07

Locations

LE (1)