Oral Sweet Solution to Prevent Pain During Neonatal Hip Examination

NCT03486015 | Completed

• 1 other identifier: 186081
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the pain relieving effect of oral glucose during hip examinations on healthy, fullterm infants.

Conditions

Pain

Outcome Measures

Primary Outcomes (5)

• Pain will be measured with ALPS-Neo (Astrid Lindgren and Lund children's hospitals pain and stress assessment scale for preterm and sick newborn infants, range 0-10 where higher number means a higher intensity of rated pain) by a nurse

  Pain assessment instrument

  The assessment is made by the nurse when the physician starts with the hip examination, approximately 60 seconds after the study solution has been given.

• Pain will be measured by VAS (Visual analogue scale, range 0-10 where higher number means a higher intensity of rated pain) assessed by physician

  Pain assessment instrument

  The physician will make the VAS assessment directly after the physical examination is done, approximately 10 minutes after the study solution has been given.

• Pain will be measured by VAS (Visual analogue scale, range 0-10 where higher number means a higher intensity of rated pain) assessed by parent

  Pain assessment instrument

  The parents will make the VAS assessment directly after the physical examination is done, approximately 10 minutes after the study solution has been given.

• Total crying time will be measured

  Total amount of time (in minutes) the infant is crying during the examination.

  The total crying time is measured throughout the examination from zero minutes until approximately 10 minutes after the study solution has been given with the help of a stopwatch.

• Crying time during hip examination

  The amount of time (in minutes) the infant is crying during the hip examination.

  The total crying time is measured from approximately 3 minutes from the study solution has been given until the hip examination has been completed (approx. during 30 sec up to 1 min) with the help of a stopwatch

Study Arms (2)

30% glucose

EXPERIMENTAL

This group will be given 2 ml of 30% glucose in the mouth before the physical examination of the infant.

Drug: 30% glucose

Sterile water

PLACEBO COMPARATOR

This group will be given 2 ml of sterile water in the mouth before the physical examination of the infant.

Drug: Sterile water

Interventions

Sterile water DRUG

2 ml of sterile water

Sterile water

30% glucose DRUG

2 ml of 30% glucose

30% glucose

Eligibility Criteria

• Age: 37 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, fullterm infants that were undergoing a routine medical examination

You may not qualify if:

• Prematurity
• Parents inability to speak Swedish well enough to give consent
• Congenital malformations or other illnesses
• Any pain-relieving medicine administered in the previous 24 hours

Sponsors & Collaborators

• Region Örebro County: lead

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 Design

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

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: April 3, 2018
• Study Start: March 1, 2016
• Primary Completion: April 10, 2017
• Study Completion: April 10, 2017
• Last Updated: April 3, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share