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Enrolling by Invitation

NCT Number: NCT06635174

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

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

Enrolling by Invitation

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Key information

Age range

1 day–90 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ali Al Qubtan

Muscat, Muḩāfaz̧at Masqaţ, 100, Oman

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dextrose

Other

we are using 2ml of 50% dextrose

normal water

Other

patient will receive 2ml of normal water

Primary outcomes

  1. 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

  2. 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. 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

  4. 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

Secondary outcomes

  1. random blood sugar

    Time frame: 10 minutes

    the random blood sugar of the patient will be compared before and after administration of oral solution

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Oman Medical Speciality Board

Other Gov

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2024
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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