Cochrane · intervention · CD011131
Infraorbital nerve block for postoperative pain following cleft lip repair in children
Feriani, G, Hatanaka, E, Torloni, MR, et al. · Cochrane Database of Systematic Reviews · 2016 · Cochrane Library
Oral HealthPain, Palliative and Supportive CareOral and maxillofacial surgery2 versionsAMSTAR 2: not assessed
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
24
current version
GRADE rated
7
No studies
8
Included studies
8
as reported
No studies 8 · 33.3%Ungraded 9 · 37.5%Very low 5 · 20.8%Low 2 · 8.3%Moderate 0 · 0%High 0 · 0%
Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.
Review question
| Element | Planned (methods) | Found (results) |
|---|---|---|
| Population | Children up to 13 years of age, undergoing cleft lip repair surgery | Children of both genders, aged 1 month to 13 years; 353 children; sample sizes 20 to 82 per study |
| Intervention | Perioperative infraorbital nerve block | Infraorbital nerve block with lignocaine (1%) or bupivacaine (0.125% to 0.5%), with or without adrenaline/epinephrine (8 studies) |
| Comparison | Another intervention (intravenous analgesia; peri-incisional infiltration); No intervention; Placebo | Placebo / sham block (3 studies); Intravenous analgesia - tramadol or fentanyl (3 studies); Anaesthetic infiltration of the incision (2 studies) |
| Outcomes | Pain measured by valid instruments (e.g. Neonatal Infant Pain Scale (NIPS); the Face, Legs, Activity, Cry, Consolability (FLACC) Scale); Duration of postoperative analgesia; Adverse events; Need for analgesic prescription for pain; Time to first analgesic requirement; Heart rate, respiratory rate, and blood pressure; Time to feeding after surgery; Duration of hospitalisation | Pain measured by valid instruments (n=353; 8 studies); Duration of postoperative analgesia (n=60; 1 study); Adverse events (5 studies); Need for analgesic prescription for pain / supplemental analgesic requirements (5 studies); Time to first analgesic requirement (5 studies); Heart rate, respiratory rate, and blood pressure (3 studies); Time to feeding after surgery (n=128; 2 studies); Duration of hospitalisation (0 studies) |
| Study designs | All randomised, published or unpublished, controlled clinical studies | Prospective, randomised, controlled, double-blind trials (single-centre) |
| Timing | Perioperative (preoperative, intraoperative, and postoperative) | Perioperative; 0 to 4 hours; first 24 hours; 1 to 8 hours; 6 hours postoperatively |
Search date: 2015-06. Databases: Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (OVID); EMBASE (OVID); LILACS
Questions and results
Show all 2 versionsPerioperative infraorbital nerve block vs Placebo (sham block)
Population: Children up to 13 years of age, undergoing cleft lip repair surgery
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Time to feeding after surgery | This outcome was not reported. | 0 studies | No studies |
Heart rate, respiratory rate, and blood pressure | Ahuja 1994: no significant difference in heart rate, respiratory rate, and blood pressure between groups. Takmaz 2009: no differences in respiratory rate and blood pressure, but children in the placebo group had… | 2 studies | Ungraded |
Duration of postoperative analgesia (in hours) | MD 8.26 [5.41, 11.11] | 1 study · 60 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Pain measured by valid instruments (mean postoperative pain score) 0 to 4 hours (peak) | SMD -3.54 [-6.13, -0.95] | 3 studies · 120 participants | Very low Downgraded: risk of bias, imprecision, inconsistency |
Time to first analgesic requirement | Takmaz 2009: time to first analgesic requirement significantly longer in the intervention than the placebo group (8.3 +/- 0.9 hours versus 1.6 +/- 0.8 hours; P = 0.001). Not pooled. | 1 study | Ungraded |
Need for analgesic prescription for pain (supplemental analgesic requirements) At 4 hours | RR 0.05 [0.01, 0.18] Low-risk population 600 per 1000; High-risk population 567 per 1000 vs Low-risk 30 per 1000 (6 to 132); High-risk 28… | 3 studies · 120 participants | Low Downgraded: risk of bias, imprecision |
Adverse events | 2 out of 3 studies reported this outcome. One study reported no differences between groups, and the other study reported more vomiting in the placebo group (Takmaz 2009: vomiting 40% placebo versus 10% intervention; P… | 2 studies | Ungraded |
Duration of hospitalisation | None of the included studies reported this outcome. | 0 studies | No studies |
Perioperative infraorbital nerve block vs Intravenous analgesia
Population: Children up to 13 years of age, undergoing cleft lip repair surgery
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Duration of hospitalisation | None of the included studies reported this outcome. | 0 studies | No studies |
Pain measured by valid instruments (mean postoperative pain score) 0 to 4 hours (first four hours after surgery) | SMD -1.50 [-2.40, -0.60] | 2 studies · 107 participants | Very low Downgraded: risk of bias, imprecision, inconsistency |
Time to feeding after surgery (in minutes) | MD -9.45 [-17.37, -1.53] | 2 studies · 128 participants | Low Downgraded: risk of bias, imprecision |
Heart rate, respiratory rate, and blood pressure | The included studies did not report these outcomes. | 0 studies | No studies |
Adverse events | 2 out of 3 studies reported this outcome. Both studies reported no difference between groups (Rajamani 2007 and Simion 2008: no adverse events attributable to either technique; Delgado 2005 did not report). | 2 studies | Ungraded |
Need for analgesic prescription for pain (supplemental analgesic requirements) | RR 0.27 [0.13, 0.55] 634 per 1000 vs 171 per 1000 (82 to 349) | 1 study · 82 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Duration of postoperative analgesia | This outcome was not reported. | 0 studies | No studies |
Time to first analgesic requirement | Not pooled (lack of data). Delgado 2005: longer in the infraorbital block group (7.3 +/- 5.1 hours) versus intravenous analgesia (2.8 +/- 2.2 hours) (P < 0.01). Simion 2008: no significant difference (195.32 +/- 71.21… | 3 studies | Ungraded |
Perioperative infraorbital nerve block vs Infiltration of the incision (peri-incisional infiltration)
Population: Children up to 13 years of age, undergoing cleft lip repair surgery
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Need for analgesic prescription for pain (supplemental analgesic requirements) | RR 0.16 [0.05, 0.51] 1000 per 1000 vs 160 per 1000 (50 to 510) | 1 study · 30 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Duration of hospitalisation | The included studies did not report this outcome. | 0 studies | No studies |
Duration of postoperative analgesia | This outcome was not reported. | 0 studies | No studies |
Time to first analgesic requirement | MD 4.92 [3.84, 6.00] | 1 study · 50 participants | Ungraded |
Pain measured by valid instruments | No numeric data available; one study reported difference favouring control group only at 6 hours postoperatively. One study reported that children in the intervention group had lower pain scores between 1 and 8 hours… | 2 studies | Ungraded |
Heart rate, respiratory rate, and blood pressure | Gaonkar 2004: no differences between groups in postoperative heart rate and blood pressure. Prabhu 1999: significantly lower heart rates in the intervention group throughout the postoperative period, and no differences… | 2 studies | Ungraded |
Time to feeding after surgery | This outcome was not reported. | 0 studies | No studies |
Adverse events | Of the 2 included studies, one study reported no difference between groups (Gaonkar 2004: no adverse events attributable to either technique), and the other study did not report this outcome. | 1 study | Ungraded |