Clinical trial NCT06635174: Efficacy of 50% Oral Dextrose As Pain Relief in Newborns Before Bladder Catheterization
Official title: Efficacy of 50% Oral Dextrose As Pain Relief in Newborns Before Bladder Catheterization
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pain Management
Neonatal Pain
Keywords: 50% dextrose
neonatal pain management
Lead sponsor: Oman Medical Speciality Board
Sponsor class: OTHER_GOV
First posted: 2024-10-10
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: change in blood pressure
timeFrame: 3 minutes, 5 minutes and 7 minutes after oral solution will be administrated
measure: change in The Neonatal Infant Pain Scale (NIPS)
timeFrame: 3 minutes, 5 minutes and 7 minutes after administration of oral solution
measure: change in the heart rate
timeFrame: 3 minutes, 5 minutes and 7 minutes after oral solution administration.
measure: change in respiratory rate
timeFrame: 3 minutes, 5 minutes and 7 minutes after oral solution administration.
Secondary outcomes:
measure: random blood sugar
timeFrame: 10 minutes
measure: the duration of crying in placebo group
timeFrame: 10 minutes
measure: the duration of crying in dextrose group
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Muscat
country: Oman
facility: Ali Al Qubtan
Study officials:
References: