Comparison of Minimal Effective Dose of Sucrose for Pain Relief in Neonates After Minor Procedure

NCT06446323 | Completed

• 1 other identifier: Rawalpindi MU
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

Type of Study: Randomized Controlled Trial Aim: To compare the effectiveness of two doses of sucrose solution for pain relief in neonates after minor procedures. Participants' Tasks: Receive either 0.2 ml or 0.5 ml of sucrose solution. Undergo minor procedures. Pain intensity assessment using the Premature Infant Pain Profile (PIPP). Comparison Groups: Researchers compared the effects of administering 0.2 ml and 0.5 ml doses of sucrose solution on post-procedural pain in neonates.

Conditions

Post Procedural Pain Management in Neonates

Keywords

sucrose solution, pain relief, neonates, minor procedure, Premature Infant Pain Profile

Outcome Measures

Primary Outcomes (1)

• pain intensity in neonates

  The primary outcome of this study is the measurement of pain intensity in neonates following minor procedures, assessed using the Premature Infant Pain Profile (PIPP). The PIPP is a validated tool used to evaluate pain in preterm and term neonates based on behavioral and physiological indicators.

  immediately after administrating the sucrose

Study Arms (2)

Group I: Neonates receiving a 0.2 ml dose of sucrose solution

ACTIVE COMPARATOR

Participants in this arm receive a 0.2 ml dose of sucrose solution. Care providers administer the specified dose of sucrose solution to neonates who have undergone minor procedures and are experiencing post-procedural pain. The dose is administered orally, following standardized protocols. Participants in this group are monitored for pain intensity using the Premature Infant Pain Profile (PIPP) by investigators who are masked to the treatment allocation. Data on pain scores and any adverse events are recorded and analyzed as part of the study.

Drug: 0.2 ml dose of sucrose

Group II: Neonates receiving a 0.5 ml dose of sucrose solution.

ACTIVE COMPARATOR

Participants in this arm receive a 0.5 ml dose of sucrose solution. Similar to Arm 1, care providers administer the specified dose orally to neonates following minor procedures. The administration is conducted according to standardized protocols. Pain intensity in this group is also monitored using the Premature Infant Pain Profile (PIPP) by investigators who remain masked to the treatment allocation. Data collected includes pain scores and any adverse events experienced by participants.

Drug: 0.2 ml dose of sucrose

Interventions

0.2 ml dose of sucrose DRUG

Both interventions aim to provide pain relief to neonates following minor procedures by administering sucrose solution orally. The study evaluates the efficacy of each dose (0.2 ml vs. 0.5 ml) in reducing post-procedural pain intensity, as measured by the Premature Infant Pain Profile (PIPP). Additionally, any adverse events associated with the administration of sucrose solution are documented and analyzed as part of the study.

Also known as: 0.5 ml dose of sucrose

Group I: Neonates receiving a 0.2 ml dose of sucrose solution; Group II: Neonates receiving a 0.5 ml dose of sucrose solution.

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy term neonates admitted to the neonatal intensive care unit (NICU) and high dependency unit (HDU) at the Department of Pediatric Surgery, Holy Family Hospital, Rawalpindi.

You may not qualify if:

• Neonates with contraindications for sucrose administration, including:
• Inability to swallow. Pharmacological muscle relaxation. Heavy sedation. Neonates who are unable to clearly view the infant's face, hindering accurate pain assessment

Sponsors & Collaborators

• Rawalpindi Medical College: lead

Study Sites (1)

Mehak Fatima

Rawalpindi, Punjab Province, 00042, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigators responsible for assessing the primary outcome measure, pain intensity using the Premature Infant Pain Profile (PIPP), are blinded to the treatment allocation. While neonates and healthcare providers administering the interventions are aware of the treatment groups, the investigators conducting the outcome assessments remain unaware of which dose of sucrose solution each neonate received. This masking of the investigators helps mitigate potential bias in the assessment of pain relief efficacy. However, it is acknowledged that complete masking of all parties involved is not feasible due to the nature of the interventions
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mehak Fatima

Model Details: In this parallel interventional study, neonates who have undergone minor procedures and are admitted to the neonatal intensive care unit are randomly assigned to one of two groups: Group I or Group II. Group I receives a 0.2 ml dose of sucrose solution, while Group II receives a 0.5 ml dose. The study follows a parallel design, where each group receives a different intervention (different doses of sucrose solution) simultaneously. This design allows for a direct comparison between the two interventions while minimizing potential biases. After administration of the respective doses, the neonates are monitored for pain intensity using the Premature Infant Pain Profile (PIPP). Data on pain scores are collected and analyzed using statistical methods, such as those performed with SPSS version 25.0. The primary objective of this parallel interventional study is to determine which dose of sucrose solution (0.2 ml or 0.5 ml) is more effective in reducing post-procedural pain in neonates.

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 6, 2024
• Study Start: March 1, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

PA (1)