Related Experiment Video
Updated: Dec 17, 2025
Acupoint Needle-Embedding Combined with Ironing Therapy for Postoperative Pain After Anal Surgery
Published on: June 23, 2023
Ibuprofen in needle procedures in children with cancer-A feasibility and pilot study
Tove Kamsvåg1, Lena Hedén1,2, Louise von Essen3
1Department of Women's and Children's Health, Pediatric Oncology, Uppsala University, Uppsala, Sweden.
Insights
This pilot study explored using oral ibuprofen for children
Area of Science:
- Pediatric Anesthesiology
- Pain Management
- Clinical Trial Feasibility
Background:
- Needle-insertion procedures in children can cause pain, fear, and distress.
- Effective pain management strategies are crucial for pediatric patients undergoing medical interventions.
- Subcutaneously implanted intravenous ports require needle access, necessitating pain mitigation.
Purpose of the Study:
- To assess the feasibility of a randomized clinical trial on oral ibuprofen for needle-insertion pain in children.
- To investigate if oral ibuprofen reduces pain, fear, and distress compared to placebo.
- To establish recruitment and protocol adherence benchmarks for future pediatric pain trials.
Main Methods:
- A pilot randomized clinical trial involving 23 children.
- Children were randomized to receive either oral ibuprofen (7.5 mg/kg) or placebo before needle insertion.
- Pain, fear, and distress were assessed by children (≥7 years), parents, and nurses; s-cortisol levels were also measured.
Main Results:
- The study did not meet key feasibility criteria, primarily due to low recruitment and consent rates.
- No trend of benefit was observed for oral ibuprofen regarding pain, fear, or distress compared to placebo.
- All feasibility criteria were met except for recruitment and patient consent.
Conclusions:
- The pilot study failed to meet feasibility targets, leading to its closure.
- While not definitively disproven, the data suggest oral ibuprofen is unlikely to be beneficial for needle-insertion pain in this context.
- Further research with improved recruitment strategies may be needed to confirm or refute ibuprofen's efficacy.
Aim:
To investigate the feasibility, and perform a pilot study, of a randomised clinical trial, investigating whether children experience less pain, fear and/or distress when they receive oral ibuprofen vs placebo before a needle is inserted in a subcutaneously implanted intravenous port.
Methods:
Twenty-three children were included consecutively and randomised to either oral ibuprofen (n = 12) 7.5 mg/kg body weight or placebo (n = 11). The child's pain, fear and distress were reported by parents, nurses and the children (if ≥7 years of age). Feasibility criteria were defined as (a) ≥4 children included/month, (b) ≥80% of eligible patients agreed to participate, (c) >90% treated according to protocol, (d) <5% missing data, (e) s-cortisol samples analysed in ≥90% of the children.
Results:
All feasibility criteria were met except recruitment and consent. Parents, nurses and children reported no trend of benefit of oral ibuprofen with regard to pain, fear and distress compared with placebo.
Conclusion:
The study failed to meet important feasibility criteria and was closed due to low recruitment rate and absence of trend of effect. From this data, we cannot state that ibuprofen is not helpful in needle procedures but that it seems unlikely.
Related Concept Videos
01:29Drug Dosing: Infants and Children
01:23Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption