Quality Improvement Protocol to Reduce Excessive Postoperative Recovery Following Cleft Palate Repair
Pediatric Anesthesia
Submitted January 2026 by Dr Tom Walker
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Summary
This Australian single-centre quality improvement (QI) study focussed on the anaesthetic management of children undergoing cleft palate repair with the primary aim of reducing PACU length of stay.
Methods
Participants were infants <36 months undergoing primary cleft palate repair (excluding cleft lip/anterior palate repairs, revisions, and pharyngoplasty).
The primary outcome measure was mean PACU length of stay. Secondary outcomes were the incidence of pain or distress, airway obstruction, hypoxaemia, or unplanned intensive care admission.
The multidisciplinary QI team included anaesthetists, plastic surgeons, and PACU nurses.
The study consisted of four non randomised sequential phases:
- A retrospective baseline phase (May 2016 – September 2020)
- Introduction of a standardised anaesthetic protocol, including paracetamol 20mg/kg, parecoxib 1mg/kg and clonidine 1- 2mcg/kg (October 2020 – January 2022)
- Introduction of selective (rather than universal) above-elbow arm splints (February 2022 – November 2023)
- Introduction of an intraoperative dexmedetomidine infusion (1 mcg/kg/hr) instead of clonidine (December 2023 – December 2024)
Results:
In total, 434 patients were studied (mean age 14.7 months; 10.1 kg), including 205 in the retrospective group, 71 in phase 2, 82 in phase 3, and 76 in phase 4.
Compared with the retrospective group, all three interventions resulted in a reduction in mean PACU length of stay, achieving the project’s predefined goal of at least a 10% reduction.
Standardisation of the anaesthetic approach resulted in 15% reduction (mean difference 23.6 minutes) in PACU length of stay, selective arm splint use result in 15% reduction (mean difference ~30.7 min) compared with phase 1, and dexmedetomidine infusion resulted in a 11% reduction (mean difference ~16.4 min) compared with phase 1
In terms of secondary outcomes, pain or distress requiring opioid rescue was 33% in the retrospective phase and was not significantly reduced in phase 2 (32%), phase 3 (32%) and phase 4 (26%). Postoperative respiratory events requiring intervention occurred in 30% in the retrospective phase and were reduced in phase 2 (18% p = 0.06), phase 3 (21%) and phase 4 (12%). The incidence of postoperative paediatric intensive care involvement reduced from 7.3% in the retrospective phase to 1.2% and 1.3% in phase 3 and 4 respectively.
The standardised anaesthetic protocol did not increase costs and was readily accepted by anaesthetic staff. The more selective use of arm splints was not associated with an increased incidence of bleeding or wound damage.
Commentary
This study demonstrates that standardised intraoperative analgesia can reduce PACU length of stay following cleft palate repair. Substantial reductions in total PACU time were compromised by prolonged wait times between being ready for PACU discharge and ward admission.
Interestingly, pain outcomes did not improve significantly with the different interventions, possibly reflecting limitations of FLACC scoring in distinguishing pain from distress, agitation, and hunger in this patient group.
The authors acknowledge that regional anaesthetic techniques such as suprazygomatic maxillary nerve blocks may represent an opportunity for prolonging time to first rescue analgesia. However, they were not incorporated into the study due to infrequent use at the study institution.
Balancing measures were reassuring, with no observed increase in bleeding or wound complications.
Take home message
Standardised anaesthetic intraoperative analgesia, including paracetamol, parecoxib and clonidine was shown to be associated with a reduction in PACU length of stay and post operative respiratory events following cleft palate repair. The addition of selective use of arm splints and replacement of clonidine with dexmedetomidine infusion was not associated with a further reduction in PACU length of stay.
This paper provides a practical and transferable framework for centres seeking to optimise postoperative recovery in this population.
Given the sequential quality improvement design, the observed improvements should be interpreted as associations rather than evidence of direct causality. The findings are most appropriately viewed as reflecting the cumulative effect of pathway standardisation and evolving practice over time, rather than the isolated impact of individual interventions.
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Consensus recommendations for paediatric airway topicalisation using lidocaine
Anaesthesia
Submitted January 2026 by Dr Roeland Passier
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Summary
This systematic literature review, followed by a three-round Delphi process, was conducted by an international expert multidisciplinary, multi-society working group. It produced consensus recommendations for paediatric airway topicalisation using lidocaine with the aim to improve the safety of this procedure.
The working group was formed and the systematic review of the literature performed to inform the recommendations in accordance with the principles of the AGREE and the PRISMA reporting checklists. The working group consisted of 24 representatives of various relevant societies and stakeholders. The initial process identified 26 articles, the results of which were subsequently used in a three-round Delphi study to formulate 21 recommendations across 5 domains of practice: dosing, recovery, adverse reactions, institutional responsibilities and learning from events. These recommendations were based on a number of factors including strength of evidence, applicability to clinical practice, multidisciplinary team involvement and practical implications.
Recommendations were graded A to D according to the strength of the available evidence and were found to be mainly C and D. The strength of recommendations judgements were graded strong (S), moderate (M) or weak (W) based on the analysis of the evidence, consensus voting and discussion through the Delphi process and were found to be mainly strong or moderate.
Recommendations included:
Dosing
- The age and weight (using ideal body weight (IBW)), concentration of solution and volume should all be taken into account when considering dosing of topical lidocaine for airway procedures (grade B, S).
- A maximum dose of 5 mg /kg may be considered safe, however more conservative doses are often effective and advised. A maximum dose of 4 mg /kg IBW is recommended if children are < 6 months, underweight or have hepatic disease.
- Two hours after the initial dose an additional dose up to 2.5 mg /kg IBW may be given. (all grade C,S).
- The maximum dose should be discussed at the pre-operative team brief (grade D,S).
- Lidocaine solutions > 4% should not be used (grade D, S), nor should solutions containing adrenaline (grade C, S)
- In children < 10 kg lidocaine 1% or 2% is recommended (grade D, M).
Recovery
- Total dose used, timings of administration (grade D, S) and time from which the child can recommence oral intake should be documented and handed over (grade D, M)
- Children should be fasted for at least 1 hour after airway topicalization, potentially longer when deemed to be at higher risk of aspiration (grade C, S)
- A period of observation should take place with nursing staff aware of signs or symptoms of aspiration and local anaesthetic systemic toxicity (LAST) (grade D,S).
Adverse reactions, institutional responsibilities and learning from events
- Adverse reactions believed to be secondary to lidocaine topicalisation should be reported and parents or guardians should be informed (grade D, S)
- 20% iv lipid emulsion should be immediately available (grade C,S). Departments should have a standard operating procedure or local guideline which is reviewed regularly and updated in line with emerging evidence. They should also regularly conduct multidisciplinary simulation training covering the management of LAST
- Shared learning from adverse events is encouraged e..g. in morbidity and mortality meetings and national database reporting (all grade D,S).
Commentary
There is a paucity of evidence, and lack of other consensus recommendations or (inter)national/ societal guidelines available on the use of lidocaine for airway topicalisation in children, despite it being common practice in paediatric anaesthesia. A recent international study showed heterogeneity in practice globally and evidence of patient harm, signalling a need for more evidence and consensus.
The aim of this study was to establish a safe and pragmatic framework to support clinical practice. The use of lidocaine in this setting is common in Australian and New Zealand practice as well, and there don’t seem to be many surprising or unexpected recommendations.
Some or all of the recommendations likely reflect current practice in most paediatric hospitals in our countries. Nevertheless this is the first time they are actually concurrently listed and backed by a broad group of experts, including representatives from both these countries and by the best available evidence. The recommendations are practical and could be implemented in our health care systems without major issues or obstructions if not yet in place, with the exception of regular multidisciplinary simulation training which potentially might be harder to implement.
Significant gaps in the current literature limit the strength of evidence supporting the recommendations. In general these are largely based on expert opinion, where the dosing recommendations were also informed by pharmacokinetic studies, although these mostly relate to intravenous administration. They purposely have a conservative approach to dosing and repeat dosing. This creates additional safety but potentially unnecessarily limits the maximum available amount that can be given, which might be problematic for longer or more stimulating procedures or younger children.
The authors note a few additional limitations of their study, including the decision not to consider use of adjuncts (such as glycopyrronium, which might influence the rate of adsorption) and not differentiating between awake, sedated and anaesthetised patients. Sedative and anaesthetic drugs such as propofol have the potential to mask some of the early signs and symptoms of LAST. This should not change the maximum amount of lidocaine that can be given but could have caused (early) signs of LAST not to be noted and reported in studies used in this review. Other factors which may be of relevance that are not discussed include the mode of delivery of the lidocaine, type of ventilation, and the surgical procedure itself. However, it would probably be unclear from the available evidence whether these factors influence the maximum dose of lidocaine that can be safely given.
As is often the case, the need for further research in this area is highlighted. Overall, the study provides a practical and well founded set of recommendations for how to increase the safety and decrease the risk of side effects and complications of paediatric airway topicalisation using lidocaine, a common procedure in paediatric anaesthesia practice.
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Comparison of analgesic efficacy and safety of caudal dexmedetomidine versus intranasal dexmedetomidine in paediatric infraumbilical surgeries
A randomised controlled trial
European Journal of Anaesthesiology
Submitted January 2026 by Dr Matt Hart
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Summary
This randomised, double-blind non-inferiority trial compared the analgesic efficacy and safety of caudal dexmedetomidine versus intranasal dexmedetomidine as an adjunct to a single-shot caudal block in children aged 1-8 undergoing infraumbilical surgery. The primary outcome was the duration of postoperative analgesia. Secondary outcomes included postoperative pain (FLACC), intra-operative fentanyl requirement, haemodynamics, postoperative sedation, emergence delirium, recovery profile, and 24 hour side effects.
A total of 64 children were randomised (32 per group) with no dropouts. Both groups received 0.2% ropivacaine 1 mL.kg-1 caudally; Group C additionally received caudal dexmedetomidine 1 µg.kg-1 and intranasal saline, whereas Group N received intranasal dexmedetomidine 1 µg.kg-1.
The duration of postoperative analgesia was similar between groups (545 ± 90 min intranasal vs. 527 ± 83 min caudal, P = 0.422). Postoperative FLACC scores were comparable at most time points, though marginally higher at 6 h and ward arrival in the caudal group. Intra-operative fentanyl supplementation and 24 hour paracetamol use were similar.
Haemodynamics were mostly comparable, although the caudal group demonstrated more episodes of intra-operative hypotension (P = 0.016) without requiring vasopressors. Sedation scores were higher in the caudal group for the first 2 hours postoperatively, but recovery times and Modified Aldrete scores were similar. No adverse events (PONV, urinary retention, bradycardia, desaturation, respiratory depression, motor block) were reported in either group.
Commentary
Dexmedetomidine has become a commonly used analgesic adjunct in paediatric anaesthesia, with both caudal and intranasal routes increasingly utilised. This study is valuable in directly comparing the two methods when used alongside a caudal block, which is an evidence gap previously noted in the literature.
Overall, this well-designed noninferiority trial demonstrates that intranasal dexmedetomidine at 1 µg.kg-1 provides postoperative analgesia equivalent to caudal dexmedetomidine when used as an adjunct to a single-shot caudal block in infraumbilical surgery. Intranasal administration avoided the transiently higher sedation and hypotension seen in the caudal dexmedetomidine group and produced a similarly smooth recovery profile, suggesting it may be a useful alternative route, particularly when minimising haemodynamic fluctuation or sedation is desirable.
However, several limitations warrant consideration. The study does not report cumulative intra-operative anaesthetic dosing, which represents a potential confounder for both the sedation profile and recovery characteristics. The proposed mechanism of action of caudal dexmedetomidine is direct action on the spinal nerves, whereas intranasal works by systemic absorption, possibly providing a degree of sedation and reduction in anaesthetic requirements. The observed difference in early postoperative sedation could therefore relate, at least in part, to variations in anaesthetic depth rather than the route of dexmedetomidine administration.
Another limitation is that the homogeneous, predominantly male, urogenital surgical population limits generalisability. Hernia repair, for example, is a common neonatal procedure where caudal anaesthesia is frequently used, and comparative data in this younger cohort would be clinically meaningful.
Furthermore, although no adverse events were observed, the sample size (64 patients) is insufficient to draw any robust conclusions regarding safety, particularly for rare but clinically important complications. Patient or carer centred outcomes such as satisfaction or quality of recovery were also not captured and would have strengthened the clinical relevance of the findings.
Future trials could examine pharmacokinetic comparisons between routes, include larger and more diverse paediatric populations, and address measures of parental satisfaction with both techniques. While this trial supports intranasal dexmedetomidine as a potentially feasible alternative to caudal administration, the small sample size and limited generalisability mean that practitioners who routinely use caudal dexmedetomidine may reasonably await further evidence before altering their current practice.
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Effects of Dexmedetomidine-Remifentanil on Neurodevelopment of Children after Inhalation Anesthesia
A Randomized Clinical Trial
Anesthesiology
Submitted January 2026 by Dr Andrew Hughes
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Overview/Summary:
This prospective, double-blind RCT compares the neurodevelopmental effect of a single GA exposure using different doses of sevoflurane in children under 2 years of age. Children were randomised to two different GA techniques: sevoflurane alone or lower-dose sevoflurane in combination with dexmedetomidine and remifentanil infusions. The results of the neurodevelopment assessment at 30 months of age are reported in this paper. The primary outcome of Full-Scale IQ assessment at 5 years of age will be reported at a later date.
Methods:
The participants were ASA 1 or 2 children between 1 month and 2 yrs of age undergoing GA for elective, nonstaged and nonrepetitive procedures (urologic, orthopaedic, general, plastic, otolaryngologic, and thoracoscopic surgeries). Exclusion criteria included a history of previous GA, known genetic or chromosomal abnormalities, developmental delay, and a range major medical conditions. Participants were withdrawn from the study if an additional GA was required during the follow up period.
Following IV induction with thiopentone and rocuronium, both groups received maintenance anaesthesia with sevoflurane. From induction through to the end of surgery, the DEX-R group received dexmedetomidine (1 mcg/kg loading dose, followed by 1 mcg/kg/hr) and remifentanil (0.1-0.2 mcg/kg/min), whereas the control group received normal saline at equivalent volumes. In both groups, sevoflurane concentration was adjusted to maintain BIS values 40-60.
Participants were assessed at approximately 30 months of age using the Korean version of the Leiter International Performance Scale (standardised nonverbal intelligence assessment tool, administered by a clinical psychologist) and the Child Behaviour Checklist (completed by a primary caregiver)
Results:
- A total of 400 participants were randomised; 345 participants were included in the final analysis (12 had unexpected additional surgeries, 42 lost to follow-up, 1 did not complete full developmental testing for unexplained reasons)
- No significant differences between groups in terms of baseline participant characteristics (mean age approximately 11 months); parental age, educational level and socioeconomic status; distribution of surgical types; duration of anaesthesia (approximately 75 minutes) or surgery; or mean BIS values
- The control group received significantly higher mean end-tidal sevoflurane concentration (2.6% +/- 0.6% vs 1.8% +/- 0.5%, p < 0.001)
- No significant difference between the groups in any of the measured neurodevelopment outcomes
- DEX-R group demonstrated lower HR and systolic BP. Only one patient in each group received vasoactive medication
Context of this study:
The important issue of whether GA causes relevant neurotoxicity in children can only be properly addressed with RCTs, as these minimise the effect of confounding factors.
However, as GA is usually required for surgery in children, there are limited clinical scenarios in which children can be randomised to GA vs no GA. To date, the GAS trial is the only RCT comparing GA vs no GA exposure. The GAS trial randomised infants having inguinal hernia repair to GA (median GA duration of 54 minutes) or awake regional anaesthesia and found no difference in neurodevelopment outcome at 5 years of age.
The CF-GAIN study evaluated children with cystic fibrosis randomised to care with differing exposure to GA in early childhood. The study enrolled children who previously participated in an RCT comparing bronchoalveolar-lavage (BAL)-directed therapy (requiring repeated GAs) to standard therapy (not requiring repeat GAs) up until 5 years of age. There were no differences in neurodevelopmental outcome between the groups at approximately 13 years old despite the BAL-directed group undergoing more GA exposures in early childhood.
The RCT discussed in this review adds to the literature by evaluating the neurodevelopmental effect of a single exposure to standard- vs lower-dose sevoflurane GA. The TREX trial, the primary results of which will be reported in the next few years, has a similar trial design, albeit with longer GA duration.
Strengths:
- This trial addresses a topic of great public interest
- It is only the second RCT designed to specifically address the neurotoxicity of sevoflurane GA in young children.
Limitations:
- There was limited separation of treatment (i.e. difference in sevoflurane concentration) between the low dose sevoflurane group and control group (mean end tidal sevoflurane concentration of 1.8% vs 2.6%). This separation is significantly less than what was achieved in the TREX trial (end tidal sevoflurane concentration 0.8% vs 2.5%). This limited dose difference may be insufficient to see an effect
- 30 months old is relatively young for assessing neurodevelopment. Assessment at 5 years old (primary outcome) may be more sensitive for detecting neurodevelopmental differences, with the potential downside of losing more patients to follow up at this later stage
- This study does not address the potential neurotoxicity of longer sevoflurane GAs (i.e. > 2 hours), or propofol-based GAs
Take home message:
The preliminary results of this trial found no neurodevelopmental differences at 30 months of age between young children exposed to a single lower-dose sevoflurane GA (supplemented with dexmedetomidine and remifentanil) compared with a single standard- dose sevoflurane GA. These results show no evidence that lower-dose sevoflurane GA is less neurotoxic, or that dexmedetomidine or remifentanil are neuroprotective in this setting.
The primary outcome results of this trial (to be assessed at 5 years of age) and the similar TREX RCT are awaited.
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