Background
Methods
Criteria | Description |
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Studies | • Randomized Controlled Trials in which midazolam was used for sedation before a procedure • No exclusions based on language or publication status |
Participants | • Adults or children • Studies that included participants undergoing dental procedures were excluded |
Interventions | • Studies that used midazolam by any route, at any dose or time, administered before a procedure • Studies that compared different drugs and different routes were excluded (e.g. intranasal midazolam plus intravenous sedative A versus intranasal sedative A plus intravenous midazolam; intravenous midazolam versus intranasal sedative A) |
Outcomes | Primary • Level of sedation on a sedation assessment scale • Anxiety • Incomplete procedures/difficulty performing procedures • Discomfort/pain Secondary • Anterograde amnesia • Over-sedation • Disinhibition or excitation • Quality of recovery • Allergic or anaphylactoid reactions • Sedation reversal • Tolerance of procedure or participant cooperation • Participant or proceduralist satisfaction |
Results
Included studies
Comparisons with new evidence available in the update
Intravenous midazolam versus intravenous placebo
Patient or population: Adults requiring sedation before gastrointestinal endoscopy and bronchoscopy, adults requiring nasogastric tube insertion in an emergency department and children Settings: Hospitals in India, Iran, UK, Portugal, USA and Japan Intervention: Intravenous midazolam Comparison: Placebo | ||||||
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Outcomes | Illustrative comparative risksa (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
Placebo | Intravenous midazolam | |||||
Level of sedation on a sedation assessment scale The Ramsay scale was used (numerical scale that ranged from 1 to 6 with higher scores indicating the participant was more sedated) | 1.19 | 1 Higher (from 0.6 higher to 1.4 higher | 100 (1 study) | Low1 ⊕⊕⊝⊝ | ||
Numeric rating of anxiety or number of participants rated as anxious Number of participants rated as anxious | 333 per 1000 | 143 per 1000 (30 to 663) | RR 0.43 (0.09 to 1.99) | 123 (2 studies) | low2 ⊕⊕⊝⊝ | |
Proportion of incomplete procedures or where there was difficulty performing the procedures | 216 per 1000 | 108 per 1000 (63 to 186) | RR 0.50 (0.29 to 0.86) | 223 (3 studies) | Low3 ⊕⊕⊝⊝ | |
Discomfort/pain | 168 per 1000 | 86 per 1000 (42 to 175) | RR 0.51 (0.25 to 1.04) | 190 (2 studies) | Low4 ⊕⊕⊝⊝ |
Oral midazolam versus chloral hydrate
Patient or population: Children requiring sedation before procedures that require motion control, including echocardiography, lumbar puncture, micturating cystourethrograms, and neuroimaging Settings: Paediatric ICU in USA, emergency departments in USA and Iran and Medical Imaging department in Turkey Intervention: Oral midazolam Comparison: Oral chloral hydrate | ||||||
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Outcomes | Illustrative comparative risksa (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
Chloral hydrate | Oral midazolam | |||||
Level of sedation on sedation assessment scale Derakhshanfar 2013 reported the number of patients reaching moderate sedation on Wheeler’s sedation scale and Salehi 2017 reported the number of patients reaching moderate sedation on the RASS scale. | 596 per 1000 | 179 per 1000 (66 to 489) | RR 0.3 (0.11 to 0.82) | 228 (2) | Very low1 ⊕⊝⊝⊝ | |
Numeric rating of anxiety or number of participants rated as anxious (numerical rating scale of 1–5 with lower scores indicating less anxiety) | 2.5 | MD was 0.77 lower2 (2.2 lower to 0.68 higher) | 88 (2) | Low3 ⊕⊕⊝⊝ | The assumed and corresponding risks were estimated from the SMD, which was − 0.26 (95% CI − 0.75 to 0.23). | |
Proportion of incomplete procedures or where there was difficulty performing the procedures | 56 per 1000 | 226 per 1000 (108 to 474) | RR 4.01 (1.92 to 8.4) | 268 (4) | Moderate4 ⊕⊕⊕⊝ | |
Discomfort/pain (as defined/measured by the authors of the trial) | No studies reported on this outcome. |
Oral midazolam versus placebo
Patient or population: Children requiring sedation before micturating cystourethrograms, and Kirschner wire removal, and adults undergoing endoscopy Settings: X-ray department in Turkey, orthopaedic outpatient department in UK, and endoscopy suites in USA and Thailand Intervention: Oral midazolam Comparison: Placebo | ||||||
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Outcomes | Illustrative comparative risksa (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
Placebo | Midazolam | |||||
Level of sedation on a sedation assessment scale (as defined/measured by the authors of the trial) | No studies reported on this outcome. | |||||
Numeric rating of anxiety or number of participants rated as anxious (as defined/measured by the authors of the trial) | 4.62 (measured on a scale that ranged from 0 to 10 with higher scores representing worse anxiety) | MD was 1.9 lower (3.5 lower to 0.3 lower) | 436(4) | Low1 ⊕⊕⊝⊝ | The assumed and corresponding risks were estimated from the SMD, which was − 1 (95% CI − 1.86 to − 0.16). | |
Proportion of incomplete procedures or where there was difficulty performing the procedures (as defined/measured by the authors of the trial) | 439 (4 studies) | Low1 ⊕⊕⊝⊝ | Relative effect was not able to be conducted because there was only one incomplete procedure in the midazolam group in one of the four trials that reported on this outcome. | |||
Discomfort/pain (as defined/measured by the authors of the trial) Scores ranged from 0 to 10 with higher score indicating more pain | 4.62 | MD was 2 lower (2.5 lower to 1.6 lower) | 99 (1 study) | Moderate1 ⊕⊕⊕⊝ |