Skip to main content
. 2017 Aug 2;2017(8):CD012537. doi: 10.1002/14651858.CD012537.pub2

Bhettay 1978.

Methods Allocation: randomised
Blinding: double‐blind
Controlled: placebo
Centre: multicentre
Arm: 2 arms, cross‐over design
Participants Inclusion criteria: children with juvenile chronic arthritis
Exclusion criteria: known history of contraindications to study drugs; receiving gold, d‐penicillamine, or corticosteroids; in a state of remission
Baseline characteristics
N = 30
Age: mean not reported, range 2 to 16 years
Gender: male (unstated); female (unstated)
Number randomised: intervention (15); control (15)
Number completed: intervention (15); control (15)
Setting and location: South Africa
Interventions Intervention group (N = 15): indomethacin (2 weeks), cross‐over ketoprofen (2 weeks)
Control group (N = 15): ketoprofen (2 weeks), cross‐over 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
Outcomes Primary outcomes
  1. Severity of pain: morning stiffness; interference with function; general feeling of well‐being; symptoms interpreted by the participant that were due to treatment; preference of either drug

  2. Articular index 0 to 4: passive movement of a joint; knee score; combined finger‐joint circumference

  3. Grip strength

  4. Temporomandibular joint

  5. Patient Impression of Change (5‐point scale)

  6. Fever, rash, splenomegaly, or lymphadenopathy

  7. Investigator's impression of change


Secondary outcomes
  1. Side effects

  2. Amount of rescue analgesia

Notes Sources of funding: Maybaker (SA) (Pty) Ltd provided drug supplies.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: Randomised drug administration, not participants
Allocation concealment (selection bias) Unclear risk Comment: Insufficient information
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Comment: Insufficient information
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: Insufficient information
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: All participants were accounted for. Lost to follow‐up and withdrawals explained.
Selective reporting (reporting bias) Unclear risk Comment: Means and standard deviations not reported, nor blood sedimentation rate, haemoglobin level, platelet and white cell count.
Size High risk Comment: Total participants = 30 (< 50 per treatment arm)
Other bias Low risk Comment: No other potential sources of bias found.