Perlin 1994.
Methods |
Allocation: randomized Controlled: placebo Blinding: double‐blind Arm: 2‐arm, parallel‐group design Centre: single centre Study Duration: unclear |
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Participants |
Inclusion criteria: aged ≥ 15 years, people with SCD admitted to emergency department with pain of VOC Exclusion criteria: active peptic ulcer disease; systemic bleeding disorders; impaired renal function (urea > 20 mg/dL /or serum creatinine > 1 mg/dL, or both); other medical condition; history of hypersensitivity to NSAIDs; pregnant women Baseline characteristics N: 21 participants; 21 VOC episodes Gender: F 10, M 11 Age (range): 19–41 years Number randomized: 10 intervention; 11 control Number completed: 9 intervention; 9 control Setting and location: Howard University Hospital, Washington, DC, USA |
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Interventions |
Treatment group (10 participants; 10 VOC episodes):
Control group (11 participants; 11 VOC episodes):
Duration of treatment: duration of crisis, 5‐day infusion period Follow‐up period: not stated Cointerventions/additional analgesia: supplemental IM meperidine 100 mg as needed, frequency no more than 3 hr |
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Outcomes |
Primary outcomes
Secondary outcomes
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Notes | Sources of funding: supported in part by a grant from Syntex Research, a division of Syntex (USA), Inc, who manufacture ketorolac as Toradol | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "the study was randomized," "The study drugs were prepared by a designated hospital pharmacist (J.P.) and allocated according to a predetermined, computer generated random code, balanced in blocks of four." |
Allocation concealment (selection bias) | Low risk | Comment: preparations by a hospital pharmacist, not study investigators. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk |
Quote: "the study drugs were prepared by a designated hospital pharmacist (J.P.) and allocated according to a predetermined, computer generated random code, balanced in blocks of four." Comment: not explicitly stated, but likely that investigators remained blinded to treatment allocation. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: not explicitly stated, but likely that investigators remained blinded to treatment allocation. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk |
Quote: "3 participants withdrawn prematurely (1‐active, 2‐control)...ITT analysis to account for withdrawals." Comment: effect not likely to be small, but appropriate ITT analysis to cope with withdrawals. |
Selective reporting (reporting bias) | Low risk | Comment: no protocol available, but all planned outcomes were reported in results |
Size | High risk | Comment: total participants 21, fewer than 50 participants per treatment arm. |
Other bias | Low risk | Comment: no other potential sources of bias. General comment: ITT analysis performed. |