Effect of high-dose paracetamol on needle procedures in children with cancer--an RCT

Area of Science:

• Pediatric Oncology
• Pain Management
• Pharmacology

Background:

• Needle insertion into implanted ports is a common procedure in pediatric oncology.
• Effective pain, fear, and distress management is crucial for young patients undergoing cancer treatment.
• Topical anesthetics are often used, but their efficacy may be enhanced by systemic analgesics.

Purpose of the Study:

• To evaluate the effectiveness of high-dose oral paracetamol in reducing pain, fear, and distress in children during needle insertion into implanted intravenous ports.
• To determine if paracetamol provides an additive analgesic effect when combined with topical anesthesia.
• To assess the impact of paracetamol on pain observation, procedure time, and cortisol levels.

Main Methods:

• A double-blind, placebo-controlled randomized controlled trial (RCT) was conducted with 51 children (1-18 years) in a pediatric oncology setting.
• Participants received either high-dose oral paracetamol (40 mg/kg) or placebo before routine needle insertion into a subcutaneously implanted intravenous port after topical anesthetic (EMLA) application.
• Pain, fear, and distress were assessed using visual analogue scales (VAS) by parents, nurses, and children (≥7 years), alongside pain observation, procedure time, and cortisol reduction.

Main Results:

• No significant differences were observed in demographic characteristics between the paracetamol and placebo groups.
• Paracetamol did not demonstrate a reduction in pain, fear, or distress compared to placebo, as reported by VAS.
• No significant differences were found in pain observation, procedure time, or cortisol reduction between the groups.

Conclusions:

• High-dose paracetamol does not provide an additive benefit in reducing pain, fear, and distress when used in conjunction with topical anesthesia for port needle insertion in children.
• The findings suggest that paracetamol may not be an effective adjunct for procedural pain management in this specific pediatric oncology context.
• Further research may be needed to explore alternative or multimodal strategies for optimizing procedural pain relief in pediatric oncology patients.