We conducted a Nominal Group Technique (NGT) investigation on the use of oral paracetamol and ibuprofen fixed-dose combination for the treatment of acute mild-to-moderate pain in children.
The NGT is a suitable method for generating ideas and consensus in a virtual format [6]. It represents a direct and structured technique based on experts’ opinion. This study used a modified NGT which included three different phases: initial phase, pre-meeting phase, final meeting phase (Fig. 1).
Fig. 1Scheme of modified NGT method
Initial phaseThe initial phase included the Board identification and the literature search.
Board identification and sharing of objectivesA medical content factory identified a Board composed of nine clinicians with experience in pediatric pain management and one pharmacologist based on their institutional affiliations and if satisfying two of the following selection criteria: documented clinical experience in one of the branches of pediatrics, being active member of scientific societies dealing with pediatric patients and pain management, publications with pediatric pain as topic (at least five in the last five years), and different background (e.g., general practitioner vs hospitalist, size of the hospital, geographic location in the country).
The survey objectives were identified by reviewing the most recent publications [7, 8] and guidelines [1, 4] on acute pain. Objectives were shared with the Board in order to collect valuable opinions and suggestions for the next step.
Literature researchWe performed a five-year (April 2017-April 2022) literature search within the PubMed database to identify the topics of the survey. The search was focused on the following keywords: paracetamol, ibuprofen, children, postoperative, headache, rheumatic pain, fixed dose, earache, musculoskeletal pain.
Filters applied during the PubMed search: in the last 5 years, Preschool Child: 2–5 years, Child: 6–12 years; Observational Study (prospective cohorts or retrospective cohorts), Review, Meta-Analysis, Systematic Reviews, Clinical Trial, Classical Article, Humans, English.
The search terms are reported in Additional file 1.
Duplicates were removed from the list of publications. Articles were screened by title and abstract to check the appropriateness of the contents with respect to the research objective. References of the selected articles were screened to search for other possibly missing articles, left out by our research.
Relevant publications on the effecacy, pharmacokinetics, and safety of the paracetamol/ibuprofen fixed-dosecombination for the treatment of acute pain [7,8,9] were analysed. National and international guidelines for the management of pain in children [1, 4] were also reviewed. The analysis also focused on even more critical aspects related to the use of ibuprofen and paracetamol in clinical practice: pain undertreatment, appropriateness of dosage regimen, compliance with guidelines by healthcare professionals, and parents [10, 11].
Pre-meeting phase and questionnairesBased on the results of the literature research, a first semi-structured open (non-anonymous) survey consisting of ten questions was developed (Table 1). The questionnaire was emailed to the Board members on May 2022 with a copy of the bibliographic search.
Table 1 First questionnairea administered to the BoardOnce collected, the results of the first questionnaire were analysed. Questions were validated if there was an agreement of ≥ 7members. On the other hand, questions were not validated if ≤ 3 members reached the agreement.
The questions and/or options that received an agreement of 4 to 6 Board members were reviewed, amended, and proposed again in a second questionnaire of the NGT survey, after an evaluation phase that involved the Board members and/or the acquisition of supporting literature. All the answers to the open questions provided by the Board were raised as multiple-choice questions.
The second questionnaire included a new multiple-choice question on the willingness of board members to use the fixed-dose combination of paracetamol and ibuprofen for the treatment of acute pain (Table 2). The second open (non-anonymous) survey was administered to the Board, starting on July 2022. Once the responses to the second questionnaire were acquired, they were processed in the form of a descriptive statistical analysis and the materials for the final meeting with the Board were prepared. The final remote meeting, on 31 August 2022 was conducted by a facilitator. All Board members were present at the meeting.
Table 2 Second questionnairea administered to the BoardThe meeting started with a summary of the results obtained from the NGT survey, followed by a brainstorming session. The debate concerned both the already validated questions and those which did not reach a qualified majority. In the final meeting the results of the two questionnaires were shared to confirm the questions validated or to reach the highest possible consensus for those with intermediate score (i.e. agreement 4–6 members). The aim of the meeting was to share experts’ opinions about the most appropriate use of oral paracetamol and ibuprofen in fixed-dose combination for pain management in children.
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