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Study flow diagram: review update.
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Figure 1

Study flow diagram: review update.

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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Forest plot of comparison: 1 Midazolam versus placebo, outcome: 1.6 Length of NICU stay (days).
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Figure 4

Forest plot of comparison: 1 Midazolam versus placebo, outcome: 1.6 Length of NICU stay (days).

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Forest plot of comparison: 1 Midazolam versus placebo, outcome: 1.9 PIPP score during drug infusion.
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Figure 5

Forest plot of comparison: 1 Midazolam versus placebo, outcome: 1.9 PIPP score during drug infusion.

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Forest plot of comparison: 2 Midazolam versus morphine, outcome: 2.2 Poor neurological outcome up to 28 days' postnatal age.
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Figure 6

Forest plot of comparison: 2 Midazolam versus morphine, outcome: 2.2 Poor neurological outcome up to 28 days' postnatal age.

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Comparison 1 Midazolam versus placebo, Outcome 1 Intraventricular haemorrhage (any grade).
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Analysis 1.1

Comparison 1 Midazolam versus placebo, Outcome 1 Intraventricular haemorrhage (any grade).

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Comparison 1 Midazolam versus placebo, Outcome 2 Mortality.
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Analysis 1.2

Comparison 1 Midazolam versus placebo, Outcome 2 Mortality.

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Comparison 1 Midazolam versus placebo, Outcome 3 Days of ventilation.
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Analysis 1.3

Comparison 1 Midazolam versus placebo, Outcome 3 Days of ventilation.

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Comparison 1 Midazolam versus placebo, Outcome 4 Days of supplemental oxygen use.
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Analysis 1.4

Comparison 1 Midazolam versus placebo, Outcome 4 Days of supplemental oxygen use.

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Comparison 1 Midazolam versus placebo, Outcome 5 Pneumothorax.
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Analysis 1.5

Comparison 1 Midazolam versus placebo, Outcome 5 Pneumothorax.

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Comparison 1 Midazolam versus placebo, Outcome 6 Length of NICU stay (days).
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Analysis 1.6

Comparison 1 Midazolam versus placebo, Outcome 6 Length of NICU stay (days).

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Comparison 1 Midazolam versus placebo, Outcome 7 Average NAPI scores at 36 weeks' PMA.
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Analysis 1.7

Comparison 1 Midazolam versus placebo, Outcome 7 Average NAPI scores at 36 weeks' PMA.

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Comparison 1 Midazolam versus placebo, Outcome 8 Poor neurological outcome by 28 days' postnatal age.
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Analysis 1.8

Comparison 1 Midazolam versus placebo, Outcome 8 Poor neurological outcome by 28 days' postnatal age.

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Comparison 1 Midazolam versus placebo, Outcome 9 PIPP score during drug infusion.
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Analysis 1.9

Comparison 1 Midazolam versus placebo, Outcome 9 PIPP score during drug infusion.

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Comparison 2 Midazolam versus morphine, Outcome 1 PIPP score during drug infusion.
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Analysis 2.1

Comparison 2 Midazolam versus morphine, Outcome 1 PIPP score during drug infusion.

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Comparison 2 Midazolam versus morphine, Outcome 2 Poor neurological outcome up to 28 days' postnatal age.
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Analysis 2.2

Comparison 2 Midazolam versus morphine, Outcome 2 Poor neurological outcome up to 28 days' postnatal age.

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Midazolam infusion compared with placebo for sedation in neonates

Patient or population: neonates requiring intubation and ventilation

Setting: neonatal intensive care unit

Intervention: midazolam infusion

Comparison: placebo infusion

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Placebo

Midazolam

Mortality

during hospital stay

High‐risk population

RR 0.79

(0.40 to 1.56)

122
(3)

⊕⊕⊕⊝
Moderate

Risk of bias for these 3 studies was low.

We noted no heterogeneity in the results (I2 = 0%).

Precision for the point estimate was low, so we downgraded the quality of the evidence 1 step.

The 3 studies were conducted in the target population of newborn infants.

220 per 1000

165 per 1000

Length of NICU stay (days)

Mean length of NICU stay ranged across control groups from 9 to 37.5 days.

WMD of NICU stay for intervention groups was 5.4 days longer.

WMD 5.4 days (0.4 to 10.5)

89
(2)

⊕⊕⊕⊝
Moderate

Risk of bias for these 2 studies was low.

We noted no heterogeneity in the results (I2 = 0%).

Precision for the point estimate was low, so we downgraded the quality of the evidence 1 step.

The 2 studies were conducted in the target population of newborn infants.

PIPP score during drug infusion

Range of scale 0‐21 for infants
< 28 weeks' PMA and
0‐18 for infants > 36 weeks'
PMA. Lower score = less pain
(Stevens 1996)

Mean PIPP score in the control group was 12.7.

Mean PIPP score in the intervention group was lower at 8.9.

MD ‐3.80
(‐5.93 to ‐1.67)

43
(1)

⊕⊕⊕⊝
Moderate

Risk of bias for this study was low.

As we identified only 1 study, tests for heterogeneity were not applicable.

Precision for the point estimate was low, so we downgraded the quality of the evidence 1 step.

This study was conducted in the target population of newborn infants.

Poor neurological outcome by 28 days' postnatal age

High‐risk population

RR 1.34
(0.50 to 3.56)

43
(1)

⊕⊕⊕⊝
Moderate

Risk of bias for this study was low.

As we identified only 1 study, tests for heterogeneity were not applicable.

Precision for the point estimate was low, so we downgraded the quality of the evidence 1 step.

This study was conducted in the target population of newborn infants.

230 per 1000

310 per 1000

*The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; MD: mean difference; NICU: neonatal intensive care unit; PIPP: Premature Infants Pain Profile; PMA: postmenstrual age; RR: risk ratio; WMD: weighted mean difference.

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.

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Midazolam infusion compared with morphine infusion for sedation in neonates

Patient or population: neonates requiring intubation and ventilation

Setting: neonatal intensive care unit

Intervention: midazolam infusion

Comparison: morphine infusion

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Morphine

Midazolam

PIPP score during drug infusion

Range of scale 0‐21 for infants
< 28 weeks' PMA and
0‐18 for infants > 36 weeks'
PMA. Lower score = less
pain (Stevens 1996)

Mean PIPP score in the control group was 7.9.

Mean PIPP score in the intervention group was 8.9.

MD 1.00
(‐0.66 to 2.66)

46
(1)

⊕⊕⊕⊝
Moderate

Risk of bias for this study was low.

As we identified only 1 study, tests for heterogeneity were not applicable.

Precision for the point estimate was low, so we downgraded the quality of the evidence 1 step.

This study was conducted in the target population of newborn infants.

Poor neurological outcome by 28 days' postnatal age

High‐risk population

RR 7.64
(1.02 to 57.21)

46
(1)

⊕⊕⊕⊝
Moderate

Risk of bias for this study was low.

As we identified only 1 study, tests for heterogeneity were not applicable.

Precision for the point estimate was low, so we downgraded the quality of the evidence 1 step.

This study was conducted in the target population of newborn infants.

318 per 1000

41 per 1000

*The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; MD: mean difference; PIPP: Premature Infants Pain Profile; PMA: postmenstrual age; RR: risk ratio.

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.

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Table 1. Sedation scores used in included studies

Study reference for included trial

Name of score used

Reference for the score

Age of infants/children subjected to the score

Score validated in newborns?

Anand 1999

COMFORT Scale

Ambuel 1992; Marx 1994

Ambuel 1992 ‐ 37 participants (age newborn to 204 months (mean 37.1; SD 52.7))

Marx 1994 ‐ children (age 0 to 102 months (mean age > 1 year)

No

Arya 2001

Sedation score

Barrier 1989

Barrier 1989 ‐ 23 infants (age 1 to 7 months)

No

Jacqz‐Aigrain 1994

Behaviour score

Craig 1984; Barrier 1989; Robieux 1991

Craig 1984 ‐ 30 children (age 2 to 24 months)

Barrier 1989; Robieux 1991 ‐ 41 infants and toddlers (age 3 to 36 months)

No
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Table 1. Sedation scores used in included studies
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Comparison 1. Midazolam versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Intraventricular haemorrhage (any grade) Show forest plot

3

122

Risk Ratio (M‐H, Fixed, 95% CI)

1.68 [0.87, 3.24]

2 Mortality Show forest plot

3

122

Risk Ratio (M‐H, Fixed, 95% CI)

0.79 [0.40, 1.56]

3 Days of ventilation Show forest plot

2

89

Mean Difference (IV, Fixed, 95% CI)

3.60 [‐0.25, 7.44]

4 Days of supplemental oxygen use Show forest plot

2

89

Mean Difference (IV, Fixed, 95% CI)

0.64 [‐5.30, 6.57]

5 Pneumothorax Show forest plot

3

122

Risk Ratio (M‐H, Fixed, 95% CI)

1.08 [0.41, 2.84]

6 Length of NICU stay (days) Show forest plot

2

89

Mean Difference (IV, Fixed, 95% CI)

5.44 [0.40, 10.49]

7 Average NAPI scores at 36 weeks' PMA Show forest plot

1

43

Mean Difference (IV, Fixed, 95% CI)

‐2.10 [‐14.38, 10.18]

8 Poor neurological outcome by 28 days' postnatal age Show forest plot

1

43

Risk Ratio (M‐H, Fixed, 95% CI)

1.34 [0.50, 3.56]

9 PIPP score during drug infusion Show forest plot

1

43

Mean Difference (IV, Fixed, 95% CI)

‐3.80 [‐5.93, ‐1.67]
Figures and Tables -
Comparison 1. Midazolam versus placebo
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Comparison 2. Midazolam versus morphine

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 PIPP score during drug infusion Show forest plot

1

46

Mean Difference (IV, Fixed, 95% CI)

1.0 [‐0.66, 2.66]

2 Poor neurological outcome up to 28 days' postnatal age Show forest plot

1

46

Risk Ratio (M‐H, Fixed, 95% CI)

7.64 [1.02, 57.21]
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Comparison 2. Midazolam versus morphine
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