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Comparison 1 Mannitol versus placebo, Outcome 1 Death.
Figuras y tablas -
Analysis 1.1

Comparison 1 Mannitol versus placebo, Outcome 1 Death.

Mannitol compared with placebo for cerebral malaria

Patient or population: Children aged 6‐60 months with cerebral malaria

Settings: Malaria endemic countries

Intervention: Intravenous mannitol administered at the same time as commencing intravenous quinine

Comparison: Placebo (5 mL/kg of saline 0.9% administered in the same way as mannitol)

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Placebo

Mannitol

Death

162 per 1000

132 per 1000
(62 to 284)

RR 0.81
(0.38‐1.74)

156
(1 study1)

low2,3,4,5

Major neurological sequelae

Not reported

Coma recovery time

156
(1 study1)

low2,3,6,7

Time to hospital discharge

Not reported

Need for ventilation

Not reported

Need for cardiopulmonary resuscitation

Not reported

Adverse events

0

0

156
(1 study1)

low3,4,5,6

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Only one randomized controlled trial of mannitol compared to placebo in children with cerebral malaria has been conducted (Namutangula 2007)
2 No serious study limitations. This study adequately randomized participants, and blinded participants to be considered at low risk of bias. The method of allocation concealment was not clearly stated but was probably done
3 No serious inconsistency. Not applicable as only one study
4 No serious indirectness. Children aged 6‐60 months who met the WHO case definition of cerebral malaria were included. Children with renal disease, cardiac failure or pulmonary congestion were excluded. 5 mL/kg of 20% mannitol (1 g/kg) or 5 mL/kg of saline as matched placebo were administered in a single dose over 20 minutes at the same time as parenteral quinine.
5 Very serious imprecision. This study is not adequately powered to detect a clinically important effect on mortality. The 95% CI is wide and includes both appreciable benefit and harm with mannitol.
6 Serious indirectness. This outcome is an indirect or surrogate indicator for poor outcomes, and on its own is not informative.
7 Serious imprecision. The article presents median times to regain conciousness, to oral intake, to sit unsupported and total coma time. The differences between the groups are not statistically significant (P > 0.05).

Figuras y tablas -
Comparison 1. Mannitol versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Death Show forest plot

1

156

Risk Ratio (M‐H, Fixed, 95% CI)

0.81 [0.38, 1.74]

Figuras y tablas -
Comparison 1. Mannitol versus placebo