An interventional study of Dextrose and normal water in Pain Management and Neonatal Pain, sponsored by Oman Medical Speciality Board. Enrolling by invitation at 1 site in Oman. Open to participants aged 1 Day to 90 Days. Per ClinicalTrials.gov, last updated 2024-10-10.
Sponsored by Oman Medical Speciality Board · Not applicable, Interventional, and Supportive care
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
Secondary Objectives
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
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.
Oman Medical Speciality Board is the lead sponsor of 15 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
in this arm participant will receive oral 2ml of normal water
Other: normal water
this arm will include the participant who will receive 50% oral dextrose
Other: Dextrose
we are using 2ml of 50% dextrose
patient will receive 2ml of normal water
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 minutes, 5 minutes and 7 minutes after oral solution administration.
random blood sugar
the random blood sugar of the patient will be compared before and after administration of oral solution
Time frame: 10 minutes
the duration of crying in placebo group
the duration of crying in placebo group will be calculated from time of starting procedure to the time in which child will stop crying
Time frame: 10 minutes
the duration of crying in dextrose group
the duration of crying in dextrose group will be calculated from time of starting procedure to the time in which child will stop crying
Time frame: 10 minutes
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan
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).
Started Oct 2024 (actual). Primary completion is estimated for Mar 2025, 4 months after the start.
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Agnosia
Oman Medical Speciality Board