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Original Investigation |

Complications of Ventilation Tube Insertion in Children With and Without Cleft Palate:  A Nested Case-Control Comparison

Ian Smillie, MRCS Ed1; Sophie Robertson1; Anna Yule1; David M. Wynne, FRCS1; Craig J. H. Russell, FRCS2
[+] Author Affiliations
1Department of Paediatric Otolaryngology–Head and Neck Surgery, Royal Hospital for Sick Children (Yorkhill), Glasgow, Scotland
2Department of Plastic Surgery, Royal Hospital for Sick Children, Glasgow, Scotland
JAMA Otolaryngol Head Neck Surg. 2014;140(10):940-943. doi:10.1001/jamaoto.2014.1657.
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Importance  Optimizing hearing in patients with cleft lip and/or palate (CLP) by early recognition and management of otitis media with effusion is essential for speech development. Some evidence has suggested higher complication rates from ventilation tube (VT) insertion in patients with CLP and has led to a trend not to treat these patients surgically. However, studies have failed to match comparison groups for age and sex.

Objective  To compare complication rates from VT insertion in pediatric patients with and without CLP.

Design, Setting, and Participants  The study used a nested case-control design to evaluate 60 pediatric patients with CLP who underwent VT insertion at a children’s hospital. The control group of age- and sex-matched patients was selected from a database of 2943 VT insertions.

Interventions  All patients were administered general anesthesia and underwent VT insertion by a pediatric otorhinolaryngology (ENT) team.

Main Outcomes and Measures  The primary outcomes were numbers of otorrhea complications. Secondarily, rates of attendance at an ENT clinic specifically for complications were evaluated. Finally, numbers of complications other than otorrhea were assessed but not statistically analyzed owing to the varied types and low numbers in each group.

Results  The control cohort had 151 documented cases of otorrhea compared with 121 in the CLP group (ratio 1.25:1); the difference between groups was not statistically significant (P = .52). There was no significant difference in mean ENT clinic visits per patient for complications between groups (0.80 in the CLP group, 0.78 for controls) (P = .66). Regarding complications other than otorrhea, the control group reported more than the CLP group (43 vs 25; ratio, 1.7:1).

Conclusions and Relevance  Complication rates of VT placement among patients with CLP were not higher than those among patients without CLP. Therefore, treatment with VT insertion should be administered to patients with CLP under the same guidelines as for those without CLP. Indeed, there could be an argument for a shift in practice toward more aggressive treatment of patients with CLP, who are already vulnerable to speech and social developmental delay.

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Figures

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Figure 1.
Otorrhea and Other Complication Rates in Patients With and Without CLP

Illustrated are the numbers of total complications, including otorrhea, occurring in all study participants. CLP indicates cleft lip and/or palate.

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Figure 2.
Otorrhea Complications in Patients With and Without CLP

Illustrated are the mean numbers of otorrhea complications per patient found in each age group. CLP indicates cleft lip and/or palate.

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Figure 3.
Otorrhea and Other Complication Rates in Patients With and Without Cleft by Sex

Illustrated are the numbers of total complications, including otorrhea, occurring in all study participants, subdivided by patient sex. CLP indicates cleft lip and/or palate.

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