Table 2.
Summary of clinical trials of paracetamol for treatment of pain in children
| Study (design; setting) | Patients (N; age range) | Treatments (n) | Regimen | Efficacy endpoint | Efficacy results (PARA vs. comparator) | Adverse events (PARA vs. comparator) |
|---|---|---|---|---|---|---|
| For pain | ||||||
| Clark et al. [66]. (R, PG; ED) | MSK trauma (336; 6–17 years) |
PARA 15 mg/kg (112) IBU 10 mg/kg (112) COD 1 mg/kg (112) |
Single dose | Change in pain VAS at 60 min |
Change in pain VAS at 60 min: –12 vs. –24 vs. –11 (both P ≤ 0.001 vs. IBU) |
Any AE: 7.7% vs. 10.9% vs. 16.2% |
| Cukiernik et al. [70]. (R, DB, PG; OP) | Soft tissue injuries to the ankle (77; 8–14 years) |
PARA 15 mg/kg (36) NAP 5 mg/kg (41) |
5 days | Change in disability and pain VAS at day 7 |
Change in disability VAS at day 7: From 7.4 to 1.0 vs. from 7.2 to 1.4 (P = 0.21) Change in pain VAS at day 7: From 6.4 to 0.5 vs. from 6.8 to 0.7 (P = 0.21) |
Any AE: 16.7% vs. 9.8% |
| Mahgoobifard et al. [68]. (R, DB, PG, PC; post-op) | Tonsillectomy (60; 4–12 years) |
PARA 15 mg/kg (18) IBU 10 mg/kg (21) PL (21) |
Single dose | Post-op pain (CHEOPS) |
Post-op CHEOPS score: 7.05 vs. 8.14 vs. 8.36 (both p = 0.001) |
NR |
| Ruperto et al. [69]. (R, DB/OL, PC; OP) | Pharyngotonsillitis (97; 6–12 years) |
PARA 12 mg/kga (34) KETO 40 mgb (33) PL (32) |
Single dose | Child-reported SPID |
Difference in child-reported SPID: PARA vs. PL (P < 0.05) PARA vs. KETO (NS) |
No serious AEs reported |
| Salmassian et al. [39]. (R, OL, PG; dental surgery) | Orthodontic tooth movement (60; 12–18 years) |
PARA 600 mg (21) IBU 400 mg (19) PL (20) |
Multiple doses | Pain VAS at peak pain after placement (19 h) |
Mean VAS at 19 h: 3.75 vs. 4.79 vs. 5.23 |
NR |
| Shepherd et al. [65]. (R, PG; ED) | Acute limb fractures (72; 5–14 years) |
PARA 15 mg/kgc (43) IBU 10 mg/kgd (29) |
48 h | Child-reported pain scores using ‘Faces’ pain scale |
Mean pain score: 2.8 vs. 2.7 (P = 0.73) |
No AEs with PARA IBU reported vomiting (2), tiredness (1) and dizziness (1) |
| For migraine | ||||||
| Hamalainen et al. [67]. (R, DB, CO, PC; OP) | Migraine (88; 4–15.8 years) |
PARA 15 mg/kg IBU 10 mg/kg PL |
Single dose | Reduction in severe or moderate headache |
Reduction in severe or moderate headache: 54% vs. 68% vs. 37% |
Any AE: 4.8% vs. 9.9% vs. 11.1% |
CHEOPS Children’s Hospital of Eastern Ontario Pain Scale, CO crossover, COD codeine, DB double blind, ED emergency department; IBU ibuprofen, MSK musculoskeletal, NAP naproxen, NR not reported, ND not significant, OL open label, OP outpatient, PARA paracetamol, PC placebo-controlled, PG parallel group, PL placebo, post-op post-operative, R randomized, SPID sum of pain intensity differences of the CSTP intensity scale by the child, VAS visual analog scale
aSyrup
bLysine salt sachet
cEvery 4 h
dEvery 8 h