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

Not Applicable

Completed

• Conditions: Immunisation Anxiety Related Reaction; Pain, Acute
• Interventions: Dietary Supplement: Sucrose

• Registration Number: NCT04103801
• Lead Sponsor: Jordan University of Science and Technology

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-14
• Primary Completion: 2017-12-20
• Study Completion: 2018-04-03
• Study First Submitted: 2018-10-17
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-24
• Last Update Submitted: 2019-09-24
• Study First Posted: 2019-09-25
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Sucrose group	Sucrose	This group received the 2 ml of sweet solution (sucrose)
Water group	Sucrose	This group received the 2 ml of water

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Substance P (SP)	Change SP level from the start of injection and up to 3 minutes after immunization	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.

Trial Locations

Locations (1)

Maternal and child health centers; 🇯🇴 Irbid, Jordan