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Boston Children's Hospital Post Anesthesia Care Unit Outcomes Study

Evaluation of Perioperative Outcomes in Children: Creation of the Boston Children's Hospital Perioperative Outcomes Registry

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02189642
Enrollment
643
Registered
2014-07-14
Start date
2013-07-13
Completion date
2017-03-08
Last updated
2017-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Procedures, Operative

Brief summary

The purpose of this study is to evaluate the quality of outcomes in the Post Anesthesia Care Unit (PACU) at BCH and to identify preoperative demographic and behavioral data as well as intraoperative and anesthetic predictors of adverse PACU outcomes. The investigators hypothesize quality of PACU outcomes will correlate with preoperative demographic and behavioral characteristics as well as intraoperative and anesthetic procedures/techniques. This study will help the investigators improve post anesthetic care quality and create a higher level of satisfaction for patients, family, and health care providers.

Interventions

None listed

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 30 Years
Healthy volunteers
No

Inclusion criteria

* All patients scheduled for surgery at Boston Children's Hospital ages 6 months to 30 years undergoing the following qualifying surgeries: Genito-Urinary/Urology Department: * Circumcision, Orchidopexy, Hypospadias Repair, Hernia Repair, Cystoscopy, Pyeloplasty, and Ureteral Reimplants or Ureteral Stents. Otolaryngology Department: * Tonsil and/or Adenoid Removal, Tympanostomy, Tympanoplasty, and Mastoidectomy. Orthopaedics Department: * Hip and Knee Arthroscopies, Hardware Removal, and Tendon Lengthening. * Plastic Surgery Department: Alveolar Cleft Repair.

Exclusion criteria

* English as a second language. * \< 6 months, \> 21 or 30 (hip patients only). * Resident of a residential facility or ward of state. * Guardianship status unclear. * Not headed to the PACU post-operatively. * Day of: Projected to arrive in PACU after 3 PM. * Duration of surgery well beyond ordinary for procedure type. * Exceptionally complex medical history.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Significant Pain in PACUOn day of surgery.Incidence of significant pain defined by pain behavior information from the Faces-Legs-Activity-Cry-Consolability (FLACC) scale, Wong-Baker Faces scale, visual analog scale/numerical scale or adapted numerical rating scale - equal to or more than 5 on a scale from 0 to 10 at any time during the PACU stay.
Incidence of Agitation in PACUOn day of surgery.Incidence of agitation using emergence agitation categorization with Pediatric Agitation Emergence Delirium (PAED) scale equal to or more than 10 on this scale for more than 30 seconds during the recovery period.
Incidence of Post-Operative Nausea or VomitingOn day of surgery.Post-operative vomiting (POV) will be measured by episodes of vomiting or retching in PACU. This will be a binary outcome - either vomiting/retching occurred or it did not.

Secondary

MeasureTime frameDescription
Satisfaction of Patients and Families with Post-Operative CareAt two days and two weeks after surgery.Satisfaction of patients and families with perioperative care, as determined from a three-question satisfaction survey allowing participating families to rate their recovery experience, global surgical experience, and need for further care at another healthcare facility.
Post-Hospitalization Behavior ChangesAt two days and two weeks after surgery.Post-hospitalization behaviors changes defined by development of 4 or more behavior changes on the Post Hospitalization Behavior Questionnaire (PHBQ) or development of increased stress levels on the Child PTSD Symptom Scale (CPSS).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026