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Completed

NCT Number: NCT02189642

Boston Children's Hospital Post Anesthesia Care Unit Outcomes Study

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.

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Key information

Conditions

Surgical Procedures, Operative

Age range

6 month–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of Significant Pain in PACU

    Time frame: On 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.

  2. Incidence of Agitation in PACU

    Time frame: On 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.

  3. Incidence of Post-Operative Nausea or Vomiting

    Time frame: On 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 outcomes

  1. Satisfaction of Patients and Families with Post-Operative Care

    Time frame: At 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.

  2. Post-Hospitalization Behavior Changes

    Time frame: At 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).

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 14, 2014
Registry last updated
Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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