Ibuprofen in needle procedures in children with cancer-A feasibility and pilot study.

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.

Prevention of oral mucositis with cryotherapy in children undergoing hematopoietic stem cell transplantations-a feasibility study and randomized controlled trial.

PURPOSE: To evaluate the feasibility of oral cryotherapy (OC) in children and to investigate if OC reduces the incidence of severe oral mucositis (OM), oral pain, and opioid use in children undergoing hematopoietic stem cell transplantation (HSCT). METHODS: Fifty-three children, 4-17 years old, scheduled for HSCT in Sweden were included and randomized to OC or control using a computer-generated list. OC instructions were to cool the mouth with ice for as long as possible during chemotherapy infusions with an intended time of ≥ 30 min. Feasibility criteria in the OC group were as follows: (1) compliance ≥ 70%; (2) considerable discomfort during OC < 20%; (3) no serious adverse events; and (4) ice administered to all children. Grade of OM and oral pain was recorded daily using the WHO-Oral Toxicity Scale (WHO-OTS), Children's International Oral Mucositis Evaluation Scale, and Numerical Rating Scale. Use of opioids was collected from the medical records. RESULTS: Forty-nine children (mean age 10.5 years) were included in analysis (OC = 26, control = 23). The feasibility criteria were not met. Compliance was poor, especially for the younger children, and only 15 children (58%) used OC as instructed. Severe OM (WHO-OTS ≥ 3) was recorded in 26 children (OC = 15, control = 11). OC did not reduce the incidence of severe OM, oral pain, or opioid use. CONCLUSION: The feasibility criteria were not met, and the RCT could not show that OC reduces the incidence of severe OM, oral pain, or opioid use in pediatric patients treated with a variety of conditioning regimens for HSCT. TRIAL REGISTRATION: ClinicalTrials.gov id: NCT01789658.