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

NCT04103801 | Completed

• 1 other identifier: 127-2015
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunisation Anxiety Related Reaction; Pain, Acute

Keywords

Sucrose,; Substance P,; Pain,; Immunization.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Substance P (SP)

  Change SP level from the start of injection and up to 3 minutes after immunization

Other Outcomes (1)

• Total crying time

  From start of injection and up to 3 minutes after the immunization

Study Arms (2)

Sucrose group

EXPERIMENTAL

This group received the 2 ml of sweet solution (sucrose)

Dietary Supplement: Sucrose

Water group

PLACEBO COMPARATOR

This group received the 2 ml of water

Dietary Supplement: Sucrose

Interventions

Sucrose DIETARY_SUPPLEMENT

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.

Also known as: Sweet solution

Sucrose group; Water group

Eligibility Criteria

• Age: 10 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All healthy children who were attending immunization clinic to have their 10-24 month immunization were invited to this study

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

Maternal and child health centers

Irbid, 21110, Jordan

Location

MeSH Terms

Conditions

Acute Pain; Pain

Interventions

Sucrose

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Manal K, PhD

  Jordan Uinversity of Sceince and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: September 25, 2019
• Study Start: July 14, 2017
• Primary Completion: December 20, 2017
• Study Completion: April 3, 2018
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)