Substance P as a Biomarker to Evaluate the Reduction of Multiple Immunization Pain

Study Overview
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Brief Summary
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Immunization is one of the most significant preventive health measures in reducing morbidity and mortality caused by infectious diseases. Studies have shown that Sucrose is recommended to reduce pain associated with vaccination in neonates. The main aim of the study was to determine the effectiveness of sucrose in reducing infant's pain outcomes during immunization among 10-24 month-old infants and toddlers.

Official Title
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Substance P as a Biomarker to Evaluate the Reduction of Multiple Immunization Pain Among Infants and Toddlers: A Randomized Controlled Trial

Conditions
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Immunisation Anxiety Related Reaction, Pain, Acute

Intervention / Treatment
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* Dietary Supplement: Sucrose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All healthy children who were attending immunization clinic to have their 10-24 month immunization were invited to this study Exclusion Criteria: Exclusion criteria included children: whose parents choose to breastfeed during immunization, who have received an analgesia in the previous 24 hours including Paracetamol (so as not to affect the response to painful stimuli during immunization), who cannot receive their immunization due to the presence of immunization risk factors as determined by the immunization nurse, who are not able to receive a sugar solution, and whose parents refuse to participate.

Ages Eligible for Study
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Minimum Age: 10 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sucrose group<br>This group received the 2 ml of sweet solution (sucrose) | Dietary Supplement: Sucrose<br>* Participants in the intervention group were given 2 ml dose of 50% sucrose solution and participants in the placebo group were given 2 ml dose of sterile water. Both groups were administered slowly over 30 seconds sublingually via needle-less syringe immediately prior to the immunization injections.<br>* Other names: Sweet solution;|
| Placebo Comparator: Water group<br>This group received the 2 ml of water | Dietary Supplement: Sucrose<br>* Participants in the intervention group were given 2 ml dose of 50% sucrose solution and participants in the placebo group were given 2 ml dose of sterile water. Both groups were administered slowly over 30 seconds sublingually via needle-less syringe immediately prior to the immunization injections.<br>* Other names: Sweet solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MBPS | Modified Behavioral Pain Scale (MBPS) is a validated procedural uni-dimensional pain measurement tool that used to measure behavioral pain outcomes. | Change MBPS score from the start of injection and up to 3 minutes after immunization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance P (SP) | Change SP level as an indicator of pain and distress level. Saliva was collected from both intervention and placebo groups immediately after treatment in the same manner and similar time schedule. Saliva specimens was immediately cooled in ice and centrifuged at 10,000g at 4 C for 15 min to obtain the supernatant. | Change SP level from the start of injection and up to 3 minutes after immunization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sucrose,, Substance P,, Pain,, Immunization.