Study | Treatment | Adverse events | Withdrawals |
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 |
Total adverse events occurring (may be more than 1 per participant): ketoprofen: 9/30 indomethacin: 9/30 No. participants reporting an adverse event: ketoprofen: 9/30 indomethacin: 9/30 Serious adverse events: ketoprofen: 0/30 indomethacin: 0/30 Specific adverse events: ketoprofen; indomethacin loss of appetite: 1/30; 1/30 nausea: 1/30; 2/30 vomiting: 3/30; 2/30 abdominal pain: 3/30; 2/30 frank blood in stool: 0/30; 1/30 headache: 1/30; 1/30 |
Total all‐cause withdrawals: ketoprofen: 0/30 indomethacin: 0/30 (1 disqualified for non‐compliance, not withdrawn) Withdrawals due to adverse events: ketoprofen: 0/30 indomethacin: 0/30 |
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 |
Total adverse events occurring (may be more than 1 per participant): fenoprofen: n = 78 aspirin: n = 90 No. participants reporting an adverse event: fenoprofen: 28/49 aspirin: 40/50 Serious adverse events: fenoprofen: 0/79 aspirin: 0/50 Specific adverse events: fenoprofen (n = 49); aspirin (n = 50) abdominal pain: 9; 10 stomach discomfort: 12; 9 diarrhoea: 4; 2 vomiting: 2; 9 nausea: 2; 3 nausea and vomiting: 0; 2 general gastrointestinal upset: 0; 2 constipation: 3; 8 anorexia: 2; 3 occult blood in stool: 0; 2 cramps, abdominal: 2; 3 diplopia: 5; 0 dizziness: 0; 2 headache: 4; 2 rash: 6; 2 fatigue: 0; 2 chills: 0; 2 hyperventilation:1; 2 SGOT increase: 0; 7 SGPT increase: 0; 6 |
Total all‐cause withdrawals: fenoprofen: 2/49 (4%); noncompliance (1); difficulty swallowing tablet (1) aspirin: 10/50 (20%); adverse effects (7); inefficacy (1); failed to co‐operate (1); wrong assignment chose to discontinue (1) Withdrawals due to adverse events: fenoprofen: 0/49 (0%) aspirin: 7/50 (14%) |
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 |
Total adverse events occurring (may be more than 1 per participant): celecoxib 3 mg/kg: 49/77 (63.6%) celecoxib 6 mg/kg: 57/82 (69.5%) naproxen 7.5 mg/kg: 60/83 (72.3%) No. participants reporting an adverse event: no data Serious adverse events: celecoxib 3 mg/kg: 3/77 celecoxib 6 mg/kg: 2/82 naproxen 7.5 mg/kg: 0/83 Specific adverse events: Significant AEs: skin and subcutaneous tissue disorders (celecoxib 6 mg; 6/82 (7.3%; P ≤ 0.10) Others AEs: eye disorders; headache (reported most often); gastrointestinal disorders; general disorders and administration site conditions; infections and infestations; injury and poisoning; investigations; musculoskeletal, connective tissue, and bone disorders; nervous system disorders; respiratory, thoracic, and mediastinal disorders |
Total all‐cause withdrawals: celecoxib 3 mg/kg: 10/77 celecoxib 6 mg/kg: 11/82 naproxen 7.5 mg/kg: 9/83 Withdrawals due to adverse events: celecoxib 3 mg/kg: 3/77 celecoxib 6 mg/kg: 7/82 naproxen 7.5 mg/kg: 3/83 |
Giannini 1990 |
Intervention group (N = 45): ibuprofen suspension (concentration 100 mg/5 mL) + 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 |
Total adverse events occurring (may be more than 1 per participant): ibuprofen: unclear aspirin: unclear No. participants reporting an adverse event: ibuprofen: 40/45 aspirin: 44/47 Serious adverse events: ibuprofen: 4/45 aspirin: 13/47 Specific adverse events: ibuprofen; aspirin abnormalities in liver function: 1/45; 22/47; P < 0.01 digestive system adverse effects: 19/45; 33/47 elevated liver enzyme values: 0/45; 5/47 abdominal pain: 0/45; 1/47 positive stool test result: 8/45; 15/47 positive faecal occult blood tests: 2/45; 1/47 |
Total all‐cause withdrawals: ibuprofen: 1/45 aspirin: 9/47 Withdrawals due to adverse events: ibuprofen: 0/45 aspirin: 6/47 |
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 |
Total adverse events occurring (may be more than 1 per participant): naproxen: 10/23 aspirin: 2/23 No. participants reporting an adverse event: naproxen: 6/23 aspirin: 1/23 Serious adverse events: naproxen: 0/23 aspirin: 0/23 Specific adverse events: naproxen: 1 ‐ abdominal pain aspirin: 1 ‐ abnormal liver test, nausea, tinnitus, and lassitude; 1 ‐ abnormal liver test; 1 ‐ vomiting |
Total all‐cause withdrawals: naproxen: 1/23 (abdominal pain) aspirin: 3/23 (1 ‐ abnormal liver test, nausea, tinnitus, and lassitude; 1 ‐ abnormal liver test; 1 ‐ vomiting) Withdrawals due to adverse events: naproxen: 1/23 aspirin: 3/23 |
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 |
Total adverse events occurring (may be more than 1 per participant): no data No. participants reporting an adverse event: LD rofecoxib: 21/109 (19.3%) HD rofecoxib: 22/100 (22%) naproxen: 28/101 (27.7%) Serious adverse events: LD rofecoxib: 0/109 HD rofecoxib: 0/100 naproxen: 0/101 Specific adverse events: Most common AEs, > 5% in each group: (n) LD rofecoxib; HD rofecoxib; naproxen abdominal pain: 7/109; 6/100; 13/101 headache: 6/109; 5/100; 13/101 upper abdominal pain: 7/109; 12/100; 7/101 nasopharyngitis: 11/109; 10/100; 1/101 pyrexia: 5/109; 4/100; 9/101 diarrhoea: 5/109; 7/100; 4/101 pharyngitis: 7/109; 3/100; 3/101 vomiting: 7/109; 3/100; 3/101 upper respiratory tract infection: 6/109; 6/100; 7/101 nausea: 3/109; 4/100; 6/101 |
Total all‐cause withdrawals: LD rofecoxib: 10/109 HD rofecoxib: 5/100 naproxen: 10/101 Withdrawals due to adverse events: LD rofecoxib: 3/109 (0.03%) HD rofecoxib: 0/100 (0.0%) naproxen: 3/101 (0.03%) |
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 |
Total adverse events occurring (may be more than 1 per participant): LD meloxicam: n = 209 HD meloxicam: n= 229 naproxen: n = 247 No. participants reporting an adverse event: LD meloxicam: 54/73 (74%) HD meloxicam: 59/74 (80%) naproxen: 66/78 (85%) Considered to be drug related: LD meloxicam: 7/73 (10%) HD meloxicam: 11/74 (15%) naproxen: 10/78 (13%) Serious adverse events: LD meloxicam: 4/73 (5%) HD meloxicam: 7/74 (9%) naproxen: 10/78 (13%) Specific adverse events: LD meloxicam (n = 73); HD meloxicam (n = 74); naproxen (n = 79) eye disorders: 5; 6; 8 gastrointestinal disorders: 28; 27; 25 pain diarrhoea, nausea, vomiting: 21; 19; 19 pharyngolaryngeal pain: 9; 5; 4 general disorders: 13; 14; 19 pyrexia: 11; 13; 14 infections and infestations: 30; 38; 39 nasopharyngitis: 4; 9; 7 physical examination: 9; 6; 4 musculoskeletal and connective tissue disorders: 11; 22; 10 nervous system disorders: 10; 11; 7 headache not otherwise specified: 9; 10; 5 respiratory, thoracic, and mediastinal disorders: 22; 19; 26 cough: 7; 9; 14 rhinitis not otherwise specified: 13; 11; 16 skin and subcutaneous tissue disorders: 4; 5; 13 eczema, erythema, pruritus, rash: 0; 3; 8 bleeding disorders (rectal haemorrhage, epistaxis, haematuria, haematoma, Henoch‐Schonlein purpura): 3; 2; 9 |
Total all‐cause withdrawals: LD meloxicam: n = 15/73 (21%). LTFU (0); AE (7); lack of efficacy (2); other (4); others (2). HD meloxicam: n = 11/74 (15%). LTFU (0); AE (3); lack of efficacy (1); other (5); others (2). naproxen: n = 17/78 (22%). LTFU (0); AE (10); lack of efficacy (3); other (4); others (0). Withdrawals due to adverse events: LD meloxicam: 7/73 (9.6%) HD meloxicam: 3/74 (4.1%) naproxen: 10/78 (12.8%) |
AE: adverse event; HD: high‐dose; LD: low‐dose; LTFU: long‐term follow‐up; N: number of participants; SGOT: serum glutamate‐oxaloacetic transaminase; SGPT: serum glutamate‐pyruvate transaminase |