Study | Treatment | Pain outcome | Other efficacy outcomes |
Bhettay 1978 |
Intervention group (N = 15): indomethacin (2 weeks) then cross‐over to ketoprofen (2 weeks) Control group (N = 15): ketoprofen (2 weeks) then cross‐over to indomethacin (2 weeks) Participants < 20 kg: ketoprofen 25 mg capsule twice daily; participants > 20 kg: ketoprofen capsules x 2 = 50 mg twice daily Participants < 20 kg: indomethacin 25 mg capsule twice daily; participants > 20 kg: indomethacin capsules x 2 = 50 mg twice daily Study duration: 5 weeks |
Participant‐reported pain relief of 30% or greater: no data Participant‐reported pain relief of 50% or greater: no data PGIC much or very much improved: no data |
Patient Global Impression of Change: no data Carer Global Impression of Change: no data Requirement for rescue analgesia: no data Sleep duration and quality: no data Acceptability of treatment: no data Physical functioning: no data Quality of life: no data |
Brewer 1982 |
Intervention group (N = 50): fenoprofen 900 mg/m2/d increased to 1800 mg/m2/d, maximum 3200 mg/d Control group (N = 49): aspirin 1500 mg/m2/d increased to 3000 mg/m2/d, maximum 5450 mg/d Study duration: 12 weeks |
Participant‐reported pain relief of 30% or greater: ≥ 25% improvement Severity of pain on movement fenoprofen: 23/50 aspirin: 21/49 Severity of limitation of movement fenoprofen: 18/50 aspirin: 16/49 Participant‐reported pain relief of 50% or greater: ≥ 50% improvement Severity of pain on movement fenoprofen: 18/50 aspirin: 15/49 Severity of limitation of movement fenoprofen: 12/50 aspirin: 12/49 PGIC much or very much improved: no data |
Patient Global Impression of Change: Patient global assessment of patient response (satisfactory) to therapy fenoprofen: 30/50 aspirin: 24/49 Carer Global Impression of Change: Parent global assessment of patient response (satisfactory) to therapy fenoprofen: 34/50 aspirin: 30/49 Physician global assessment of patient response fenoprofen: 31/50 aspirin: 31/49 Requirement for rescue analgesia: no data Sleep duration and quality: no data Acceptability of treatment: no data Physical functioning: no data Quality of life: no data |
Foeldvari 2009 |
Intervention group (N = 77): celecoxib 50 mg/5 mL oral suspension (target dose approximately 3 mg/kg twice daily) Intervention group (N = 82): celecoxib 100 mg/5 mL oral suspension (target dose approximately 6 mg/kg twice daily) Control group (N = 83): naproxen 125 mg/5 mL oral suspension (target dose approximately 7.5 mg/kg twice daily) Study duration: 12 weeks |
Participant‐reported pain relief of 30% or greater: ACR Pediatric‐30 responders, n (%) celecoxib 3 mg/kg: 53/77 (68.8%) celecoxib 6 mg/kg: 66/82 (80.5%) naproxen 7.5 mg/kg: 56/83 (67.5%) Participant‐reported pain relief of 50% or greater: no data PGIC much or very much improved: no data |
Patient Global Impression of Change: no data Carer Global Impression of Change: Parent global assessment of overall well‐being 100‐millimetre VAS, least squares mean change from baseline (SE) celecoxib 3 mg/kg: ‐17.96 (2.42) celecoxib 6 mg/kg: ‐20.45 (2.34) naproxen 7.5 mg/kg: ‐18.25 (2.33) Physician global assessment of disease activity: 100‐millimetre VAS, least squares mean change from baseline (SE) celecoxib 3 mg/kg: ‐21.07 (1.86) celecoxib 6 mg/kg: ‐23.27 (1.80) naproxen 7.5 mg/kg: ‐21.88 (1.79) Requirement for rescue analgesia: no data Sleep duration and quality: no data Acceptability of treatment: no data Physical functioning: Parent assessment of physical functioning, Child Health Assessment Questionnaire, disability index 0 to 3, least squares mean change from baseline (SE) celecoxib 3 mg/kg: ‐0.28 (0.05) celecoxib 6 mg/kg: ‐0.32 (0.05) naproxen 7.5 mg/kg: ‐0.31 (0.05) Quality of life: Pediatric Quality of Life Inventory All treatment groups improved Pediatric Quality of Life Inventory scores. Scores of participants in the celecoxib 6 mg/kg twice‐daily group or naproxen 7.5 mg/kg twice‐daily group were higher than those of participants in the celecoxib 3 mg/kg twice‐daily group, but results were non‐significant (data not shown in publication). Unclear whether differences are between groups or over time. celecoxib 3 mg/kg: no data celecoxib 6 mg/kg: no data naproxen 7.5 mg/kg: no data |
Giannini 1990 |
Intervention group (N = 45): ibuprofen suspension (concentration 100 mg/5mL) + placebo aspirin Control group (N = 47): aspirin 200 mg tablet (participant weight 10 to 30 kg) or 300 mg capsules (participant weight > 30 kg) + placebo ibuprofen Week 2: physician's option to increase dose to 40 mg/kg/day ibuprofen or 80 mg/kg/day aspirin, provided no significant side effects Study duration: 12 weeks |
Participant‐reported pain relief of 30% or greater: no data Participant‐reported pain relief of 50% or greater: no data PGIC much or very much improved: Patient Global Impression of Change very much improved: ibuprofen: 22/26 (85%) aspirin: 18/20 (90%) Carer Global Impression of Change: ibuprofen: 33/42 (79%) aspirin: 29/35 (83%) Investigator Global Evaluation: ibuprofen: 34/44 (78%) aspirin: 27/35 (77%) |
Patient Global Impression of Change: ibuprofen: 22/26 (85%) aspirin: 18/20 (90%) Carer Global Impression of Change: ibuprofen: 33/42 (79%) aspirin: 29/35 (83%) Investigator Global Evaluation: ibuprofen: 34/44 (78%) aspirin: 27/35 (77%) Requirement for rescue analgesia: no data Sleep duration and quality: no data Acceptability of treatment: no data Physical functioning: no data Quality of life: no data |
Moran 1979 |
Intervention group (N = 23): naproxen 10 mg/kg/24 hrs given as a suspension in 2 divided doses Control group (N = 23): aspirin soluble 80 mg/kg/day, divided into 4 doses Study duration: 2 x 4 weeks |
Participant‐reported pain relief of 30% or greater: no data Participant‐reported pain relief of 50% or greater: no data PGIC much or very much improved: no data |
Patient Global Impression of Change: no data Carer Global Impression of Change: no data Requirement for rescue analgesia: no data Sleep duration and quality: no data Acceptability of treatment: Medication preference at end of trial: Naproxen much better: 0 Naproxen better: 9 Both periods equal: 9 Aspirin better: 4 Aspirin much better: 1 Physical functioning: no separate data Quality of life: no data |
Reiff 2006 |
Intervention group (N = 209): (children) LD rofecoxib 0.3mg/kg/day maximum 12.5mg/day, or HD rofecoxib 0.6mg/kg/day maximum 25 mg/day; (adolescents) rofecoxib 12.5 or 25 mg daily Control group (N = 101): (children) naproxen 15 mg/kg/day 5 mg oral suspension; (adolescents) 15 mg/kg/day maximum 1000 mg/day Study duration: 12 weeks |
Participant‐reported pain relief of 30% or greater: ACR Pedi 30% reduction LD rofecoxib: 45/97 (46.2%) HD rofecoxib: 49/90 (54.5%) naproxen: 48/87 (55.1%) Participant‐reported pain relief of 50% or greater: no data PGIC much or very much improved: no data |
Patient Global Impression of Change: no data Carer Global Impression of Change: no data Patient/Parent Global Assessment of Pain: mean change from baseline (95% CI) LD rofecoxib: ‐12.50 (‐15.98; ‐9.02) HD rofecoxib: ‐13.12 (‐16.75; ‐9.48) naproxen: ‐8.43 (‐11.98; ‐4.88) Requirement for rescue analgesia: no data Sleep duration and quality: no data Acceptability of treatment: no data Physical functioning: CHAQ index: mean change from baseline (95% CI) LD rofecoxib: ‐0.11 (‐0.18; ‐0.05) HD rofecoxib: ‐0.15 (‐0.21; ‐0.08) naproxen: ‐0.12 (‐0.18; ‐0.05) Quality of life: Patient/parent assessment of overall well‐being:mean change from baseline (95% CI) (proportion of improvement from baseline) LD rofecoxib: ‐11.57 (‐14.78; ‐8.36) (74.3%) HD rofecoxib: ‐12.08 (‐15.44; ‐8.73) (76%) naproxen: ‐8.56 (‐11.85; ‐5.27) (73%) Additional data Investigators' global assessment of disease activity: mean change from baseline (95% CI) LD rofecoxib: ‐12.45 (‐14.95; ‐9.94) HD rofecoxib: ‐13.27 (‐15.88; ‐10.65) naproxen: ‐12.05 (‐14.60; ‐9.50) |
Ruperto 2005 |
Intervention group 1 (N = 73): LD meloxicam 0.125 mg/kg, 1 dose per day Intervention group 2 (N = 74): HD meloxicam 0.25 mg/kg, 1 dose per day Control group (N = 78): naproxen 5 mg/kg, twice per day Study duration: 48 weeks |
Participant‐reported pain relief of 30% or greater: @ 3 MONTHS LD meloxicam: 46/73 (63%), 95% CI 52 to 74% HD meloxicam: 43/74 (58%), 95% CI 47 to 69% naproxen: 50/78 (64%), 95% CI 53 to 75% @ 12 MONTHS LD meloxicam: 56/73 (77%), 95% CI 67 to 86% HD meloxicam: 56/74 (76%), 95% CI 66 to 85% naproxen: 58/78 (74%), 95% CI 65 to 84% Participant‐reported pain relief of 50% or greater: @ 3 MONTHS LD meloxicam: 38/73 (52%), 95% CI 41 to 64% HD meloxicam: 32/74 (43%), 95% CI 32 to 55% naproxen: 39/78 (50%), 95% CI 39 to 61% @ 12 MONTHS LD meloxicam: 50/73 (68%), 95% CI 58 to 79% HD meloxicam: 48/74 (65%), 95% CI 54 to 76% naproxen: 53/78 (68%), 95% CI 58 to 78% TOTAL POOLING: P = 0.7 PGIC much or very much improved: no data |
Patient Global Impression of Change: no data Participant reported assessment of discomfort (facial affective scale 1 to 9 points): @ 3 MONTHS LD meloxicam: 0.3 ± 0.2 HD meloxicam: 0.4 ± 0.2 naproxen: 0.3 ± 0.2 @ 12 MONTHS LD meloxicam: 0.3 ± 0.2 HD meloxicam: 0.3 ± 0.2 naproxen: 0.2 ± 0.2 Physician global impression of disease activity (VAS 0 to 100): @ 3 MONTHS LD meloxicam: 19.4 ± 20.7 HD meloxicam: 20.6 ± 20.3 naproxen: 21.1 ± 19.2 @ 12 MONTHS LD meloxicam: 15.4 ± 20.5 HD meloxicam: 16.8 ± 19.0 naproxen: 14.4 ± 16.7 Carer Global Impression of Pain (VAS 0 to 100): @ 3 MONTHS LD meloxicam: 17.6 ± 20.2 HD meloxicam: 21.9 ± 23.6 naproxen: 20.8 ± 22.4 @ 12 MONTHS LD meloxicam: 13.4 ± 17.6 HD meloxicam: 17.2 ± 22.5 naproxen: 15.9 ± 21.3 Requirement for rescue analgesia: no data Sleep duration and quality: no data Acceptability of treatment: no data Physical functioning: CHAQ Disability Index (0 to 3 points) @ 3 MONTHS LD meloxicam: 0.4 ± 0.5 HD meloxicam: 0.5 ± 0.6 naproxen: 0.5 ± 0.6 @ 12 MONTHS LD meloxicam: 0.3 ± 0.4 HD meloxicam: 0.4 ± 0.6 naproxen: 0.3 ± 0.5 Quality of life: no data |
ACR: American College of Rheumatology; CI: confidence interval; HD: high‐dose; LD: low‐dose; N: number of participants; PGIC: Patient Global Impression of Change;SE: standard error; VAS: visual analogue scale |