Clinical trial NCT02189642: Boston Children's Hospital Post Anesthesia Care Unit Outcomes Study
Official title: Evaluation of Perioperative Outcomes in Children: Creation of the Boston Children's Hospital Perioperative Outcomes Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Procedures, Operative
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2014-07-14
Enrollment: 643
Sex: ALL
Minimum age (years): 6
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators will enroll all patients 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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Significant Pain in PACU
timeFrame: On day of surgery.
measure: Incidence of Agitation in PACU
timeFrame: On day of surgery.
measure: Incidence of Post-Operative Nausea or Vomiting
timeFrame: On day of surgery.
Secondary outcomes:
measure: Satisfaction of Patients and Families with Post-Operative Care
timeFrame: At two days and two weeks after surgery.
measure: Post-Hospitalization Behavior Changes
timeFrame: At two days and two weeks after surgery.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References: