Boston Children's Hospital Post Anesthesia Care Unit Outcomes Study

NCT02189642 | Completed

• 1 other identifier: IRB-P00008050
• Study Type: observational
• Target: 643
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Procedures, Operative

Outcome Measures

Primary Outcomes (3)

• Incidence of Significant Pain in PACU

  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.

  On day of surgery.

• Incidence of Agitation in PACU

  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.

  On day of surgery.

• Incidence of Post-Operative Nausea or Vomiting

  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.

  On day of surgery.

Secondary Outcomes (2)

• Satisfaction of Patients and Families with Post-Operative Care

  At two days and two weeks after surgery.

• Post-Hospitalization Behavior Changes

  At two days and two weeks after surgery.

Study Arms (4)

Genito-Urinary/Urology Surgical Procedure Types

Pediatric patients undergoing circumcision, orchidopexy, hypospadias repair, hernia repair, cystoscopy, pyeloplasty, and ureteral reimplants or ureteral stents.

Otolaryngology Surgical Procedure Types

Pediatric patients undergoing tonsil and/or adenoid removal, tympanostomy, tympanoplasty, and mastoidectomy.

Orthopaedics Surgical Procedure Types

Patients undergoing hip and knee arthroscopies, hardware removal, and tendon lengthening.

Plastic Surgery Surgical Procedure Type

Pediatric patients undergoing alveolar cleft repair.

Eligibility Criteria

• Age: 6 Months - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology, Senior Associate

Study Record Dates

• First Submitted: July 11, 2014
• First Posted: July 14, 2014
• Study Start: July 13, 2013
• Primary Completion: March 8, 2017
• Study Completion: March 8, 2017
• Last Updated: March 10, 2017

Record last verified: 2017-03

Locations

US (1)