Clinical trial NCT06446323: Comparison of Minimal Effective Dose of Sucrose for Pain Relief in Neonates After Minor Procedure
Official title: Comparison of Minimal Effective Dose of Sucrose for Pain Relief in Neonates After Minor Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Procedural Pain Management in Neonates
Keywords: sucrose solution, pain relief, neonates, minor procedure, Premature Infant Pain Profile
Lead sponsor: Rawalpindi Medical College
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 148
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: pain intensity in neonates
timeFrame: immediately after administrating the sucrose
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Mehak Fatima
state: Punjab
Study officials:
References: