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Table 3 Questions approved at final meeting and clinician' responses

From: Paracetamol and ibuprofen combination for the management of acute mild-to-moderate pain in children: expert consensus using the Nominal Group Technique (NGT)

N

Question

Option answers validated at the second questionnair

Clinician’ answers (n = 10)

Approved at final meeting

1

Would you use the fixed combination for the treatment of postoperative pain?

Option Yes (validated at the first round)

9

Confirmed consensus at the final meeting

2

Derived from the open field of the first round

In which cases would you use the fixed combination for the treatment of postoperative pain (having assessed the antiplatelet effect of ibuprofen in order not to compromise hemostasis)?

When both anti-inflammatory

and analgesic effects are desired (validated at the first round)

8

Confirmed consensus at the final meeting

When paracetamol alone

does not control pain

6

Agreed consensus following brainstorming

3

The fixed combination in the pediatric setting is effective in case of:

Odontalgia (validated at the first round)

10

Confirmed consensus at the final meeting

Headaches (validated at the first round)

9

Confirmed consensus at the final meeting

Earache (validated at the first round)

8

Confirmed consensus at the final meeting

Musculoskeletal pain (validated at the first round)

8

Confirmed consensus at the final meeting

Chronic rheumatic pain (option derived from the open field of first round)

8

Confirmed consensus at the final meeting

4

Reintroduced with rewording of the answer options based on first round results

In the pediatric field, the oral suspension of the fixed combination would be preferred because:

It optimizes the dosage in relation to the weight of the child (reworded from the first round)

7

Confirmed consensus at the final meeting

It reduces parental dosing errors compared to the combined administration of two separate drugs (derived from the open field of first round)

9

Confirmed consensus at the final meeting

It allows for quick pain control with greater effectiveness (derived from the open field of first round)

5

Agreed consensus

following brainstorming

5

What are the factors that could make the fixed combination effective?

Complementarity of the mechanisms of action (validated at the first round)

9

Confirmed consensus at the final meeting

Synergy between the effects of the two substances (validated at the first round)

7

Confirmed consensus at the final meeting

6

What do you think are the possible implications in terms of safety and tolerability of the fixed combination?

Superior analgesia compared to single drugs used alone without compromising tolerability (validated at the first round)

9

Confirmed consensus at the final meeting

7

Reintroduced for intermediate agreement of the first round

What do you think is the pharmacodynamic advantage of the fixed combination?

Greater analgesic power

8

Confirmed consensus at the final meeting

8

In case of inefficacy of paracetamol alone, would you use the fixed combination?

Option Yes (validated at the first round)

8

Confirmed consensus at the final meeting

9

Derived from the open field of first round

In case of inefficacy of paracetamol alone, would you use the fixed combination?

Headaches

5

Agreed consensus to all options at the last meetinga

Earache

6

Post-traumatic musculoskeletal pain

9

Odontalgia

7

Moderate pain that does not respond to the administration of ibuprofen alone in the first instance

8

Confirmed consensus at the final meeting

10

--In case of inefficacy of ibuprofen alone, would you use the fixed combination?

Option Yes (validated at the first round)

8

Confirmed consensus at the final meeting

11

Derived from the open field of first round

In case of inefficacy f ibuprofen alone, would you use the fixed combination?

Headaches

7

Agreed consensus to all options at the last meetinga

Chronic rheumatic painb

5

Post-traumatic musculoskeletal pain

8

Odontalgia

8

Moderate pain that does not respond to the administration of paracetamol alone in the first instance

7

Confirmed consensus at the final meeting

12

--Would you use the fixed combination for acute pain treatment?c

Moderate (4–6 score)

7

Confirmed consensus at the final meeting

  1. aFor questions 9 and 11, independently the minimal difference between the Clinician' answers, the Board agreed that the combination of paracetamol and ibuprofen would be the better choice in case of inefficacy of the 2 drugs as monotherapy especially in case of headache, earache, odontalgia, and musculoskeletal pain
  2. bThe chronic rheumatic pain was included in the more general group of musculoskeletal pain
  3. cReference was made to the scales approved and used in Italy depending on age: FLACC (Face-Legs-Activity-Crying-Consolability) for children < 3 years, WONG-BAKER for children up to 8 years, NRS (Numeric Rating Scale) for older children