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Meta-Analysis
. 2016 May 20;2016(5):CD009491.
doi: 10.1002/14651858.CD009491.pub2.

Midazolam for sedation before procedures

Aaron Conway  1 , John Rolley, Joanna R Sutherland
Affiliations
Meta-Analysis

Midazolam for sedation before procedures

Aaron Conway et al. Cochrane Database Syst Rev. .

Abstract

Background: Midazolam is used for sedation before diagnostic and therapeutic medical procedures. It is an imidazole benzodiazepine that has depressant effects on the central nervous system (CNS) with rapid onset of action and few adverse effects. The drug can be administered by several routes including oral, intravenous, intranasal and intramuscular.

Objectives: To determine the evidence on the effectiveness of midazolam for sedation when administered before a procedure (diagnostic or therapeutic).

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL to January 2016), MEDLINE in Ovid (1966 to January 2016) and Ovid EMBASE (1980 to January 2016). We imposed no language restrictions.

Selection criteria: Randomized controlled trials in which midazolam, administered to participants of any age, by any route, at any dose or any time before any procedure (apart from dental procedures), was compared with placebo or other medications including sedatives and analgesics.

Data collection and analysis: Two authors extracted data and assessed risk of bias for each included study. We performed a separate analysis for each different drug comparison.

Main results: We included 30 trials (2319 participants) of midazolam for gastrointestinal endoscopy (16 trials), bronchoscopy (3), diagnostic imaging (5), cardioversion (1), minor plastic surgery (1), lumbar puncture (1), suturing (2) and Kirschner wire removal (1). Comparisons were: intravenous diazepam (14), placebo (5) etomidate (1) fentanyl (1), flunitrazepam (1) and propofol (1); oral chloral hydrate (4), diazepam (2), diazepam and clonidine (1); ketamine (1) and placebo (3); and intranasal placebo (2). There was a high risk of bias due to inadequate reporting about randomization (75% of trials). Effect estimates were imprecise due to small sample sizes. None of the trials reported on allergic or anaphylactoid reactions. Intravenous midazolam versus diazepam (14 trials; 1069 participants)There was no difference in anxiety (risk ratio (RR) 0.80, 95% confidence interval (CI) 0.39 to 1.62; 175 participants; 2 trials) or discomfort/pain (RR 0.60, 95% CI 0.24 to 1.49; 415 participants; 5 trials; I² = 67%). Midazolam produced greater anterograde amnesia (RR 0.45; 95% CI 0.30 to 0.66; 587 participants; 9 trials; low-quality evidence). Intravenous midazolam versus placebo (5 trials; 493 participants)One trial reported that fewer participants who received midazolam were anxious (3/47 versus 15/35; low-quality evidence). There was no difference in discomfort/pain identified in a further trial (3/85 in midazolam group; 4/82 in placebo group; P = 0.876; very low-quality evidence). Oral midazolam versus chloral hydrate (4 trials; 268 participants)Midazolam increased the risk of incomplete procedures (RR 4.01; 95% CI 1.92 to 8.40; moderate-quality evidence). Oral midazolam versus placebo (3 trials; 176 participants)Midazolam reduced pain (midazolam mean 2.56 (standard deviation (SD) 0.49); placebo mean 4.62 (SD 1.49); P < 0.005) and anxiety (midazolam mean 1.52 (SD 0.3); placebo mean 3.97 (SD 0.44); P < 0.0001) in one trial with 99 participants. Two other trials did not find a difference in numerical rating of anxiety (mean 1.7 (SD 2.4) for 20 participants randomized to midazolam; mean 2.6 (SD 2.9) for 22 participants randomized to placebo; P = 0.216; mean Spielberger's Trait Anxiety Inventory score 47.56 (SD 11.68) in the midazolam group; mean 52.78 (SD 9.61) in placebo group; P > 0.05). Intranasal midazolam versus placebo (2 trials; 149 participants)Midazolam induced sedation (midazolam mean 3.15 (SD 0.36); placebo mean 2.56 (SD 0.64); P < 0.001) and reduced the numerical rating of anxiety in one trial with 54 participants (midazolam mean 17.3 (SD 18.58); placebo mean 49.3 (SD 29.46); P < 0.001). There was no difference in meta-analysis of results from both trials for risk of incomplete procedures (RR 0.14, 95% CI 0.02 to 1.12; downgraded to low-quality evidence).

Authors' conclusions: We found no high-quality evidence to determine if midazolam, when administered as the sole sedative agent prior to a procedure, produces more or less effective sedation than placebo or other medications. There is low-quality evidence that intravenous midazolam reduced anxiety when compared with placebo. There is inconsistent evidence that oral midazolam decreased anxiety during procedures compared with placebo. Intranasal midazolam did not reduce the risk of incomplete procedures, although anxiolysis and sedation were observed. There is moderate-quality evidence suggesting that oral midazolam produces less effective sedation than chloral hydrate for completion of procedures for children undergoing non-invasive diagnostic procedures.

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Conflict of interest statement

Aaron Conway: none known

John Rolley is currently researching aspects of pre‐procedural sedation and fasting for people undergoing diagnostic and interventional cardiac catheterization laboratory procedures. He has no relationships with any company providing drugs associated with this systematic review.

Joanna Sutherland was a member of the working party reviewing ANZCA PSO9 prior to 2014 and was the Clinical Lead for the NSW Agency for Clinical Innovation working party which developed the Minimum Standards for Safe Procedural Sedation.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 Intravenous midazolam versus diazepam, Outcome 1 Number of participants rated as 'anxious'.
1.2
1.2. Analysis
Comparison 1 Intravenous midazolam versus diazepam, Outcome 2 Participant co‐operation (not co‐operative).
1.3
1.3. Analysis
Comparison 1 Intravenous midazolam versus diazepam, Outcome 3 Participant satisfaction.
1.4
1.4. Analysis
Comparison 1 Intravenous midazolam versus diazepam, Outcome 4 Proceduralist satisfaction.
1.5
1.5. Analysis
Comparison 1 Intravenous midazolam versus diazepam, Outcome 5 Difficulty performing procedures (rated as difficult to perform procedure).
1.6
1.6. Analysis
Comparison 1 Intravenous midazolam versus diazepam, Outcome 6 Onset of sedation.
1.7
1.7. Analysis
Comparison 1 Intravenous midazolam versus diazepam, Outcome 7 Anterograde amnesia (defined as the number of participants who recalled procedure).
1.8
1.8. Analysis
Comparison 1 Intravenous midazolam versus diazepam, Outcome 8 Quality of recovery (rated as delayed recovery).
1.9
1.9. Analysis
Comparison 1 Intravenous midazolam versus diazepam, Outcome 9 Discomfort/Pain.
2.1
2.1. Analysis
Comparison 2 Intravenous midazolam versus placebo, Outcome 1 Vital signs (mean lowest oxygen saturation).
2.2
2.2. Analysis
Comparison 2 Intravenous midazolam versus placebo, Outcome 2 Vital signs (oxygen desaturation).
2.3
2.3. Analysis
Comparison 2 Intravenous midazolam versus placebo, Outcome 3 Vital signs (hypotension).
2.4
2.4. Analysis
Comparison 2 Intravenous midazolam versus placebo, Outcome 4 Vital signs (tachycardia).
2.5
2.5. Analysis
Comparison 2 Intravenous midazolam versus placebo, Outcome 5 Vital signs (hypertension).
3.1
3.1. Analysis
Comparison 3 Oral midazolam versus chloral hydrate, Outcome 1 Incomplete procedure.
3.2
3.2. Analysis
Comparison 3 Oral midazolam versus chloral hydrate, Outcome 2 Onset time of sedation.
3.3
3.3. Analysis
Comparison 3 Oral midazolam versus chloral hydrate, Outcome 3 Offset time of sedation.
4.1
4.1. Analysis
Comparison 4 Intranasal midazolam versus placebo, Outcome 1 Incomplete procedure.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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References to studies awaiting assessment

Bardhan 1984 {published data only}
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References to ongoing studies

NCT00563069 {unpublished data only}
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NCT01925898 {unpublished data only}
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Puttapitakpong 2015 {unpublished data only}
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References to other published versions of this review

Morão 2011
    1. Morão S, Ratilal BO, Santos H, Sampaio C. Midazolam for sedation before procedures. Cochrane Database of Systematic Reviews 2011, Issue 12. [DOI: 10.1002/14651858.CD009491] - DOI