Efficacy of 50% Oral Dextrose As Pain Relief in Newborns Before Bladder Catheterization

October 9, 2024 updated by: Ali Redha Taqi Al Qubtan, Oman Medical Speciality Board

The aim of this study is to determine the effect of 50% oral dextrose in reducing pain before Bladder Catheterization.

This study will answer the following question

Is there any effect of 50% dextrose in reducing pain response to infants from age 1-90 days undergoing bladder catheterization during their visit in emergency department it is double blind randomized control trial comparing 2ml 50% dextrose as oral solution with placebo 2ml of normal water

Primary Objective

- To evaluate the impact of administrating oral glucose on pain control compared with placebo in blood pressure , Heart rate, respiratory rate and oxygen saturation before and after the procedure

Secondary Objectives

  • To compare random blood sugar before and after the procedure
  • To compare the incident and the duration of crying in both groups

administration of oral solution 2ml of solutions to be administered orally as drops at tip of the tongue after that will wait for 2 minutes before the procedure start , after 2 minutes from the oral solution , the procedure will start

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

During first days of the life of New-borns, they go through a lot of painful procedures such as blood tests and immunizations that lead to painful experiences and distress. For long period of time it was believed that young children do not feel the painful stimuli. Recent studies have proven that they have all the anatomical, physiological and neurochemical system to feel for the pain (1). In fact, they have low threshold for the pain stimuli due to immature suppressive mechanism (2). There are several consequences that pain can cause to children such as: respiratory distress, changes in the metabolic and intracranial system, induce significant behavioural reactions and increase sensitivity to pain.

For these reasons, as well as for ethical reasons, it is advisable to find an acceptable method to reduce pain and distress during painful procedures. Pharmacologic treatment is not recommended for New-borns with acute, recurring, and short-term painful procedures. Studies has reported an alternative way which can be used for pain relive such as using oral sweeteners (3). World-widely, national and international guidelines recommended the use of oral sweeteners such as Sucrose and glucose before painful procedures (4). Researchers found that administration of oral dextrose can raise the pain threshold by activating endogenous opioids (5). The maximum effect can be observed at 2 minutes after administration (6). It is not clear what is the exact effective dose that can be used during painful procedure (7). Several studies used 2ml of dextrose, but other studies have reported an effect with 0.05 mL (8).

Study done by thyr et al (9) shows sweet solution can be used as a simple and safe method to reduce the distress following immunization in infants up to 12 months. A systematic review by Harrison et al (10) reported that Infants aged 1-12 months received oral sucrose or glucose before immunization had moderately reduced incidence and duration of crying.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Oman
      • Muscat, Oman, 100
        • Ali Al Qubtan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age from 1 day to 90 days
  • Did not received analgesia for last 6 hours

Exclusion Criteria:

  • Preterm newborns presenting in ED younger than 38 weeks (corrected age)
  • Unstable child
  • Suspicion of enterocolitis
  • Esophageal- tracheal fistula not operated
  • Known case of fructose intolerance
  • Oral congenital malformation (cleft palate)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control group
in this arm participant will receive oral 2ml of normal water
Other: normal water
patient will receive 2ml of normal water
Experimental: 50% dextrose group
this arm will include the participant who will receive 50% oral dextrose
Other: Dextrose
we are using 2ml of 50% dextrose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in blood pressure
Time Frame: 3 minutes, 5 minutes and 7 minutes after oral solution will be administrated

blood pressure will be measured before the procedure and 3 minutes, 5 minutes and 7 minutes after oral solution administration. each vital will be analyzed as single variable comparing it with the baseline.

for example (baseline blood pressure will be compared with the blood pressure during procedure after oral solution) the different of both blood pressure will be analyzed whiter there is significant change or not in both group
3 minutes, 5 minutes and 7 minutes after oral solution will be administrated
change in The Neonatal Infant Pain Scale (NIPS)
Time Frame: 3 minutes, 5 minutes and 7 minutes after administration of oral solution
the Neonatal Infant Pain Scale (NIPS) will be calculated by trained treating nurse staff 3 minutes, 5 minutes and 7 minutes after administration of oral solution
3 minutes, 5 minutes and 7 minutes after administration of oral solution
change in the heart rate
Time Frame: 3 minutes, 5 minutes and 7 minutes after oral solution administration.

heart rate will be measured before the procedure and 3 minutes, 5 minutes and 7 minutes after oral solution administration. each vital will be analyzed as single variable comparing it with the baseline.

for example (baseline heart rate will be compared with the heart rate during procedure after oral solution) the different of both heart rate will be analyzed whiter there is significant change or not in both group
3 minutes, 5 minutes and 7 minutes after oral solution administration.
change in respiratory rate
Time Frame: 3 minutes, 5 minutes and 7 minutes after oral solution administration.

respiratory rate will be measured before the procedure and 3 minutes, 5 minutes and 7 minutes after oral solution administration. each vital will be analyzed as single variable comparing it with the baseline.

for example (baseline respiratory rate will be compared with the respiratory rate during procedure after oral solution) the different of both heart rate will be analyzed whiter there is significant change or not in both group
3 minutes, 5 minutes and 7 minutes after oral solution administration.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
random blood sugar
Time Frame: 10 minutes
the random blood sugar of the patient will be compared before and after administration of oral solution
10 minutes
the duration of crying in placebo group
Time Frame: 10 minutes
the duration of crying in placebo group will be calculated from time of starting procedure to the time in which child will stop crying
10 minutes
the duration of crying in dextrose group
Time Frame: 10 minutes
the duration of crying in dextrose group will be calculated from time of starting procedure to the time in which child will stop crying
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oman Medical Speciality Board

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

October 3, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

October 10, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OmanMedAQ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data obtained through this study may be provided to qualified researchers with academic interest in randomized control trials. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.

IPD Sharing Time Frame

Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis

IPD Sharing Access Criteria

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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