Comparison of Minimal Effective Dose of Sucrose for Pain Relief in Neonates After Minor Procedure
- Conditions
- Post Procedural Pain Management in Neonates
- Interventions
- Drug: 0.2 ml dose of sucrose
- Registration Number
- NCT06446323
- Lead Sponsor
- Rawalpindi Medical College
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 148
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group II: Neonates receiving a 0.5 ml dose of sucrose solution. 0.2 ml dose of sucrose 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. Group I: Neonates receiving a 0.2 ml dose of sucrose solution 0.2 ml dose of sucrose 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.
- Primary Outcome Measures
Name Time Method pain intensity in neonates immediately after administrating the sucrose 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mehak Fatima
🇵🇰Rawalpindi, Punjab, Pakistan