Citation | Study group | Study type | Outcome | Key result | Comments |
Babl et al 200910 |
| Double-blinded superiority RCT |
Primary outcome: Median researcher-observed FLACC score at (i) baseline (ii) nebulisation (iii) rest (iv) restraint (v) NGT insertion (vi) post-procedure recovery Secondary outcomes: (i) Median researcher-observed VAS score for pain and distress for the above time points (i) to (vi) (ii) Median nurse-observed and guardian-observed VAS scores for pain and distress of (i) nebulisation and (ii) NGT insertion |
No differences in median FLACC scores during insertion: Lidocaine 9.8 (IQR 9–10) vs placebo 9.5 (IQR 9–10). p=0.46 High median FLACC scores during nebulisation: Lidocaine 6.3 (IQR 3.0–8.0) vs placebo 6.0 (IQR 1.5–8.0). p=0.76 Trend to post-procedural FLACC reduction: lidocaine 3.5 (IQR 1.5–6.0) vs placebo 5.5 (IQR 3.5–7.0). p=0.10 Reduced median nurse-observed pain (VAS score) post-procedure with lidocaine: Lidocaine 22 mm (IQR 12–37 mm); placebo 47 mm (IQR 25–56 mm). p=0.05 | Trial stopped before full recruitment of the planned 52 patients due to unacceptable levels of distress during nebulisation so not adequately powered |
Craig et al 201911 |
| Double-blinded superiority RCT |
Primary outcome: Median staff observer FLACC score during (i) NGT insertion (ii) pre-procedure+recovery periods Secondary outcomes: (i) Median staff observer VAS score for pain and distress (completed post-procedure) (ii) Median guardian VAS score for pain+distress (completed post-procedure) |
No difference in median FLACC scores: test group 9 (IQR 7–10) vs placebo group 9 (IQR 8–10). p=0.21 No difference in median staff observer VAS scores for distress (test group 71.5 vs placebo group 75.5. p=0.72) or for pain (test group 38 vs placebo group 33. p=0.85) No difference in guardian observer VAS scores for distress (test group 69 vs placebo group 76.5. p=0.93) or for pain (test group 45 vs placebo group 44.5. p=0.08) | Convenience sampling, thus more unwell children likely not included in study. Lidocaine doses significantly lower than those used in other areas of clinical paediatrics, eg. flexible bronchoscopy |
FLACC, Face, Legs, Activity, Crying, Consolability score; NG, nasogastric tube; RCT, randomised controlled trial; VAS score, Visual Analogue Scale score (0 mm=no pain/distress and 100 mm=worst pain/distress).