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

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.

Study Overview

• Status: Completed
• Conditions: Post Procedural Pain Management in Neonates
• Intervention / Treatment: Drug: 0.2 ml dose of sucrose

Detailed Description

This study is a randomized controlled trial conducted at the Department of Pediatric Surgery, Holy Family Hospital, Rawalpindi, from March 2023 to February 2024. It aims to compare the effectiveness of two different doses of sucrose solution (0.2 ml versus 0.5 ml) for pain relief in neonates after minor procedures.

Objective:

To compare the outcome of 0.2 ml versus 0.5 ml sucrose solution for pain relief in neonates after minor procedures.

Study Design:

Randomized Controlled Trial

Study Place and Duration:

Department of Pediatric Surgery, Holy Family Hospital, Rawalpindi, March 2023 to February 2024.

Participants and Methods:

Total of 148 neonates enrolled who underwent minor procedures and were admitted to the neonatal intensive care unit.

Randomly divided into two groups:

Group I: Administered 0.2 ml of sucrose solution Group II: Administered 0.5 ml of sucrose solution Pain intensity measured using the Premature Infant Pain Profile (PIPP). Data analyzed using SPSS version 25.0.

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 00042
      • Mehak Fatima

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I: Neonates receiving a 0.2 ml dose of sucrose solution; 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; 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.; Other Names: 0.5 ml dose of sucrose
Active Comparator: Group II: Neonates receiving a 0.5 ml dose of sucrose solution.; 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; 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.; Other Names: 0.5 ml dose of sucrose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rawalpindi Medical College

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: May 31, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: sucrose solution, pain relief, neonates, minor procedure, Premature Infant Pain Profile
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pain, Procedural
• Other Study ID Numbers: Rawalpindi MU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

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