NCT06446323

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Rawalpindi Medical College · Academic / Other
• Sex: All
• Age: 1 Day – 30 Days
• Healthy volunteers: Accepted

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.

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.

Conditions

• Post Procedural Pain Management in Neonates

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-02-29
• Completion: 2024-02-29
• First posted: 2024-06-06
• Last updated: 2024-06-06

Locations

1 site across 1 country: Pakistan