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

NCT06635174 | Enrolling By Invitation DMC

• 1 other identifier: OmanMedAQ
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain Management; Neonatal Pain

Keywords

50% dextrose; neonatal pain management

Outcome Measures

Primary Outcomes (4)

• change in blood pressure

  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)

  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

  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

  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 Outcomes (3)

• random blood sugar

  10 minutes

• the duration of crying in placebo group

  10 minutes

• the duration of crying in dextrose group

  10 minutes

Study Arms (2)

control group

PLACEBO COMPARATOR

in this arm participant will receive oral 2ml of normal water

Other: normal water

50% dextrose group

EXPERIMENTAL

this arm will include the participant who will receive 50% oral dextrose

Other: Dextrose

Interventions

Dextrose OTHER

we are using 2ml of 50% dextrose

50% dextrose group

normal water OTHER

patient will receive 2ml of normal water

control group

Eligibility Criteria

• Age: 1 Day - 90 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oman Medical Speciality Board: lead

Study Sites (1)

Ali Al Qubtan

Muscat, Muḩāfaz̧at Masqaţ, 100, Oman

Location

Related Links

• Related Info

MeSH Terms

Conditions

Agnosia

Interventions

Glucose

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; 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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomization will be generated at the local pharmacy by a computer program in blocks of two and the randomization allotment only will be known by a pharmacist not involved in the care of the children. after that the pharmacist will prepper the syringe than contain the 2ml 50% dextrose or the placebo 2ml normal water. each syringe will have code. the code key will be only with the pharmacist.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: emergency resident

Model Details: Total of 90 patient divided randomly in 2 groups, one group will receive 2ml of 50% oral dextrose and control group will receive 2ml of normal water as placebo. The Neonatal Infant Pain Scale (NIPS) will be used to measure the pain score among the infants. It was designed and validated in Canada by Lawrence J Alcock D et al. It uses the behaviors that nurses have described as being indicative of infant pain or distress. It is composed of six (6) Parameters Facial expression Cry Breathing patterns Arms Legs State of arousal

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 10, 2024
• Study Start: October 9, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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
• 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).

Locations

OM (1)