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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Acute; Immunisation Anxiety Related Reaction
• Intervention / Treatment: Dietary supplement: Sucrose

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Irbid, Jordan, 21110
    • Maternal and child health centers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 months to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sucrose group; This group received the 2 ml of sweet solution (sucrose)	Dietary supplement: Sucrose; 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.; Other Names: Sweet solution
Placebo Comparator: Water group; This group received the 2 ml of water	Dietary supplement: Sucrose; 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.; Other Names: Sweet solution

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total crying time	The total crying time duration in minute was measured (using the video) from start of injection and to post-immunization Crying	From start of injection and up to 3 minutes after the immunization

Collaborators and Investigators

• Sponsor: Jordan University of Science and Technology
• Investigators: Principal Investigator: Manal K, PhD, Jordan Uinversity of Sceince and Technology

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2017
• Primary Completion (Actual): December 20, 2017
• Study Completion (Actual): April 3, 2018

Study Registration Dates

• First Submitted: October 17, 2018
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Pain,; Sucrose,; Substance P,; Immunization.
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: 127-2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data is confidential and could not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No