Sickle cell disease: methylprednisolone had no clear effect.

Clinical bottom line (level 1b-)

  1. Children and adolescents with sickle cell disease and acute severe pain who were given methylprednisolone, had no clear difference in acute chest syndrome or readmission with pain than those given placebo.
  2. Methylprednisolone may reduce the length of time analgesia is required for.
Griffin et al: New England Journal of Medicine 1994; 330 (11): 733-737
Expires February 2003

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: children's hospital, USA

36 patients (aged range 2 to 19 years; mean 8, 50% male) sickle cell disease and acute severe pain unresponsive to fluid and analgesia at home and in the emergency department

Excluded if
  • >21 years old
  • pain lasting >4 days
  • strong suspicion of bacterial infection
  • acute chest syndrome (chest wall pain with acute pulmonary infiltrate or signs of respiratory distress or both)


    • Note:
  • 56 episodes of acute severe pain occurred, and these were used instead of the patient number for analyses.


    • Control Group: (n = 30, 30 analysed): saline iv once daily on two consecutive days
    Experimental Group: (n = 26, 26 analysed): methylprednisolone 15 mg/kg (max 1000 mg) iv given as soon as possible at admission and a second dose 24 hours later
    All patients were given iv fluids and iv morphine as necessary.
    100% followed for 2 weeks

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    acute chest syndrome 4 days 4
    (13.3%)    		 3
    (11.5%)    		 13.0%
    (-252% to 79.0%)    		 1.79%
    (-15.5% to 19.1%)    		 56
    (NNT = 5 to infinity;
    NNH = 6 to infinity)
    readmission with pain 2 weeks 1
    (3.33%)    		 4
    (15.4%)    		 -362%
    (-3774% to 45.0%)    		 -12.1%
    (-27.3% to 3.23%)    		 -8
    (NNT = 31 to infinity;
    NNH = 4 to infinity)

    Outcome Control Group
    (SD)    		 Experimental Group
    (SD)    		 Mean Difference
    (95% CI)
    analgesic treatment time (hours) 71.3
    ()     		41.3
    ()     		30.0
    ( to )

  • The mean difference in analgesic treatment time was significant, p=0.03.
  • No adverse effects from steroids were noted.

    • Comments

    1. The study was too small to make useful comments about the therapy.
    2. Episodes of severe pain were used instead of patient number for analysis of data, so results may be exaggerated.

    Citation

    1. Griffin TC, McIntire D, Buchanan GR: High-dose intravenous methylprednisolone therapy for pain in children and adolescents with sickle cell disease. New England Journal of Medicine 1994; 330 (11): 733-737
    Contributor: Chris Ball and Clare Wotton, February 2000
    Reviewer:

    Clinical Question.
    Patient sickle cell disease
    Intervention or Exposure methylprednisolone
    Comparison placebo
    Outcome pain