Summary of findings 5. Scalp infiltration compared with control or placebo intervention for prevention of pain in adults undergoing brain surgery.
| Scalp infiltration compared with control or placebo intervention for prevention of pain in adults undergoing brain surgery | |||||||
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Patient or population: adults undergoing brain surgery Settings: hospitals, countries: France, India, USA, Saudi Arabia, Greece, Thailand and China Intervention: scalp Infiltration Comparison: control or placebo Intervention |
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| Outcomes | Absolute Effect (95% CI) | Relative Effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | ||
| Asuumed Risk | Corresponding Risk | ||||||
|
Acute postoperative pain 0 to 6 hours (Score 0 to 10, VAS or NRS Scale) |
The mean pain scores in the control group ranged from 2.0 to 5.4 | Mean difference in pain intensity was 0.64 points lower in those who received scalp infiltration when compared with those who received control or placebo interventions (1.28 points lower to 0.00 points lower) | Not applicable | 475 (9) |
⊕⊕⊕⊝ moderate 1 | ||
|
Acute postoperative pain at 12 hours (Score 0 to 10, VAS or NRS Scale) |
The mean pain scores in the control group ranged from 1.6 to 5.0 | Mean difference in pain intensity was 0.71 points lower in those who received scalp infiltration when compared with those who received control or placebo interventions (1.34 points lower to 0.08 points lower) | Not applicable | 309 (7) |
⊕⊕⊝⊝ low 2 | ||
|
Acute postoperative pain at 24 hours (Score 0 to 10, VAS or NRS Scale) |
The mean pain scores in the control group ranged from 1.1 to 5.0 | Mean difference in pain intensity was 0.39 points lower in those who received scalp infiltration when compared with those who received control or placebo interventions (1.06 points lower to 0.27 points higher) | Not applicable | 260 (6) |
⊕⊕⊕⊝ moderate 1 | ||
| Acute postoperative pain at 48 hours (score 0 to 10, VAS or NRS scale) | The mean pain scores in the control group ranged from 2.3 to 3.8 | Mean difference in pain intensity was 1.09 points lower in those who received scalp infiltration when compared with those who received control or placebo interventions (2.13 points lower to 0.06 points lower) | Not applicable | 128 (3) |
⊕⊕⊕⊝ moderate 3 | ||
|
Additional analgesia requirements 0 to 24 hours (milligrams) |
Mean additional analgesia requirement in the control group ranged from 13 mg to 58 mg | Mean difference in additional analgesia requirements in the first 24 hours after surgery 9.56 mg less in those who received scalp infiltration when compared with those who received control or placebo interventions (15.64 mg less to 3.49 mg less) | Not applicable | 345 (6) |
⊕⊝⊝⊝ very low 4 | ||
| Analgesic Success | 8 percent of patients in the control group were pain‐free at 6 hours | 4 percent of patients in the treatment group were pain‐free at 6 hours | Not applicable | 49 (1) |
⊕⊝⊝⊝ very low 5 | Only one study addressed this outcome | |
| Sedation | Not calculated | Not calculated | Not applicable | Not applicable | Not applicable | No eligible study addressed this outcome | |
| Chronic headache | Not calculated | Not calculated | Not applicable | Not applicable | Not applicable | No eligible study addressed this outcome | |
| Length of critical care stay (hours) | Not calculated | Not calculated | Not calculated | Not applicable | Not applicable | No eligible study addressed this outcome | |
| Length of hospital stay (hours) | Not calculated | Not calculated | Not calculated | Not applicable | Not applicable | No eligible study addressed this outcome | |
|
Adverse event nausea and vomiting (0 to 24 hours) |
236 per 1000 | 174 per 1000 | Risk of nausea and vomiting was 0.74 times less in those who received scalp infiltration when compared with those who received control or placebo interventions (0.48 to 1.41) | 318 (4) |
⊕⊕⊝⊝ low 6 | ||
| CI: Confidence interval; RR: Risk Ratio; VAS: Visual Analogue Scale; NRS: Numerical Rating Scale | |||||||
| 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. | |||||||
- Consistency, precision, directness was rated high. The evidence was downgraded by one level due to inconsistency in the form of unexplained important heterogeneity.
- The evidence was downgraded by two levels due to imprecision due to a small pooled sample size and loss of significance of results on sensitivity analysis.
- The evidence was downgraded by one level due to a small pooled sample size.
- The evidence was downgraded three levels due to imprecision due to a small pooled sample size, inconsistency in the form of unexplained important heterogeneity and loss of significance of results on sensitivity analysis.
- The evidence was downgraded by three levels as the results came from one small study.
- The evidence was downgraded two levels level due to imprecision i.e. a small number of total events and a wide 95% confidence that included the possibility of either no effect or increased nausea and vomiting in the intervention group.