Dataset Information

Taste and/or Odour Disturbances in Pediatric Patients Undergoing IV Flush with Normal Saline Administered by Prefilled Syringe.

ABSTRACT: BACKGROUND:At the Children's Hospital of Eastern Ontario, more than 6000 inpatients per year undergo IV saline flushes by prefilled syringe to assess and maintain patency of IV tubing. In studies involving adults, it has been reported that volatile substances may leach from syringe materials into the saline, leading to taste and/or odour disturbances. OBJECTIVE:To determine the incidence of taste and/or odour disturbances in pediatric patients after flushing of IV tubing with 0.9% sodium chloride (normal saline [NS]) from prefilled syringes. METHODS:Inpatients aged 5-18 years who had undergone routine flushing of central or peripheral IV tubing with commercially available prefilled NS syringes were interviewed. Children aged 5-10 years used a visual hedonic scale to rate taste and odour sensations, and those aged 11-18 years used a numeric rating scale. RESULTS:During the study period (April to July 2011), a total of 104 pediatric inpatients (21 aged 5-10 years and 83 aged 11-18 years) underwent NS flushing of central (10 patients [10%]) or peripheral (94 patients [90%]) tubing. For 100 of these patients, BD Posiflush NaCl 0.9% 10-mL sterile prefilled syringes were used, and for 4 patients BD Saline XS NaCl 0.9% 10-mL sterile prefilled syringes were used. Taste and/or odour disturbances were reported by 76 (73%) of the patients. Twelve patients described more than one taste or odour sensation. Taste and odour disturbances were detected by children in both age groups. CONCLUSIONS:Flushing of IV tubing with prefilled NS syringes resulted in taste and/or odour disturbances in a pediatric population.

SUBMITTER: Celetti SJ

PROVIDER: S-EPMC3477834 | biostudies-literature | 2012 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Taste and/or Odour Disturbances in Pediatric Patients Undergoing IV Flush with Normal Saline Administered by Prefilled Syringe.

Celetti Steven J SJ Vaillancourt Régis R Pascuet Elena E Sharp Diane D

The Canadian journal of hospital pharmacy 20120901 5

<h4>Background</h4>At the Children's Hospital of Eastern Ontario, more than 6000 inpatients per year undergo IV saline flushes by prefilled syringe to assess and maintain patency of IV tubing. In studies involving adults, it has been reported that volatile substances may leach from syringe materials into the saline, leading to taste and/or odour disturbances.<h4>Objective</h4>To determine the incidence of taste and/or odour disturbances in pediatric patients after flushing of IV tubing with 0.9% ...[more]

PMID: 23129865

Similar Datasets

Project description:IntroductionPegfilgrastim-cbqv (UDENYCA®; Coherus BioSciences, Redwood City, CA, USA) is a pegfilgrastim (Neulasta®; Amgen, Thousand Oaks, CA, USA) biosimilar approved for administration by prefilled syringe (PFS). The recently approved pegfilgrastim-cbqv prefilled autoinjector (AI) was developed as another method of self-administration and to aid in-office use, providing flexibility in drug delivery. The objectives of the study were to assess the pharmacokinetics (PK) and pharmacodynamics (PD) to determine bioequivalence of the prefilled AI and the PFS for administration of pegfilgrastim-cbqv and to assess the safety profile of the prefilled AI.MethodsDuring this open-label, two-period crossover study, healthy adult males (N = 155) were randomly assigned (1:1 ratio) to receive a subcutaneous injection of pegfilgrastim-cbqv using a prefilled AI (n = 76) or a PFS (n = 79) in period 1. During period 2, participants received an injection using the other method. Primary PK and secondary PD parameters were calculated to assess the bioequivalence of the treatment as administered by the two delivery methods. Safety and immunogenicity were also assessed.ResultsThe 90% CIs of the geometric mean ratios for the PK and PD parameters were within the required range (80-125%), demonstrating bioequivalence between the pegfilgrastim-cbqv prefilled AI and PFS. Treatment-emergent adverse events (TEAEs) were reported by 75% and 74.1% of participants in the prefilled AI and PFS groups, respectively. The most common TEAEs in both treatment groups were myalgia, bone pain, and headache. AI-device-related TEAEs were injection site pain (1.4%) and injection site bruising (0.7%). The incidence of antidrug antibodies and neutralizing antibodies was low and was similar in both treatment sequences.ConclusionsThe bioequivalence of pegfilgrastim-cbqv administered using a prefilled AI and a PFS was established. The safety, including immunogenicity profiles, of pegfilgrastim-cbqv administered using the prefilled AI and the PFS were similar, with no new safety findings.

Project description:PurposeThis multicenter, randomized, crossover study compared preference, ease of use, acceptability, satisfaction, and safety of repeated subcutaneous (SC) self-administrations with prefilled pens and prefilled syringes delivering methotrexate (MTX), in patients with rheumatoid arthritis (RA).Patients and methodsThe study (ClinicalTrials.gov number NCT01793259) enrolled 120 patients requiring initiation or intensification of MTX therapy for RA. Patients were randomized to receive the test drug, a prefilled pen (Metex(®) PEN/Metoject(®) PEN), or the reference drug, a prefilled syringe (Metex(®)/Metoject(®)), at doses of 15, 17.5, or 20 mg MTX SC once a week for 3 weeks. This was followed by receipt of the reference drug (prefilled syringe) or the test drug (prefilled pen) in a crossover design, with each patient serving as his/her own control. Questionnaires regarding patient preference, the Self-Injection Assessment Questionnaire (SIAQ), and diaries regarding local tolerability were used to document outcomes.ResultsOverall patient preference for the MTX prefilled pen was 75% (P<0.0001). In a six-item questionnaire, 73% to 76% of the patients preferred the prefilled pen in relation to use, acceptability, and satisfaction, and 67% of the patients confirmed that it did not take much effort to overcome SC self-injection with the pen. The SIAQ showed no clinical differences, in any domain scores, between both devices. Overall patient attitude towards self-injection at baseline was positive, as was patient experience with both devices during the study. As well, 92% of physicians and study nurses indicated that they would recommend the MTX prefilled pen to patients for future MTX treatment. The formulations were generally well tolerated.ConclusionSC self-injection of MTX with a prefilled pen was generally preferred, by patients with RA, over a prefilled syringe with regard to use, acceptability, and satisfaction. This is supported by the strong appreciation of their attending study nurses and physicians, for its convenience.

Dataset Information

Taste and/or Odour Disturbances in Pediatric Patients Undergoing IV Flush with Normal Saline Administered by Prefilled Syringe.

Publications

Taste and/or Odour Disturbances in Pediatric Patients Undergoing IV Flush with Normal Saline Administered by Prefilled Syringe.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets