Pain at Home After Tonsillectomy With or Without Adenoidectomy
Condition: Sleep Apnea; Adenotonsillectomy; Pediatric ALL
Study type: Observational

Summary: 
      The study type is a prospective observational cohort study of children undergoing
      adenotonsillectomy (T&A). The study will recruit the annual caseload of children undergoing
      T&A at the Montreal Children's Hospital, QC, Canada; aiming for 200 children. There are no
      interventions.

      The purpose of this study is to determine the severity and duration of postoperative pain
      after T&A and to link the severity of this pain with the severity of sleep disordered
      breathing.
    

Detailed description: 
      Adenotonsillectomy (T&A) is one or the most common surgeries performed in children. Even
      though T&A is considered a painful surgery, it is often scheduled as a day surgery and
      parents manage the postoperative pain at home. Historically, the home analgesic following
      adenotonsillectomy consisted of a combination of acetaminophen and codeine. In June 2013,
      Health Canada no longer recommended the use of codeine in children less than 12 years of age.
      Thus in current practice the discharge analgesic is a combination of ibuprofen, acetaminophen
      and oral rescue morphine. This shift in practice has occurred globally as well as in our
      institution without evaluating the impact on analgesia at home following T&A.

      The published literature reports that as many as 50% of children managed with the
      acetaminophen/codeine regimen visit a primary care physician for the management of
      pain/infection following T&A and a high proportion of these children are prescribed an
      opioid. This practice is of concern for the following reasons. Sleep disordered breathing
      (SDB) is the most common indication for T&A in children. In some children the sleep
      disturbance meets the diagnostic criteria for obstructive sleep apnea (OSA). A subset of
      children, with severe OSA are more sensitive to both the analgesic and respiratory effects of
      opioids. In these children, an age-appropriate dose of opioids may result in an overdose.

      Study Design:

      Pain will be measured in hospital and at home with validated pain scores. The primary outcome
      measure is the Parents' Postoperative Pain Measure (PPPM), a valildated, established metric,
      with good construct and content validity, for the repeated evaluation of pain following
      surgery in the home environment. Parents will be asked to record the both the pain scores,
      twice daily for 14 days.

      A secondary outcome measure will be the self report of pain from the children. Two validated
      pain scales will be used. For pre-verbal children, the Face, Legs, Activity, Cry and
      Consolability (FLACC) pain scale will be used. This 0-10 scale has shown good reliability,
      validity and relevance in clinical practice for children's less than 4 years of age for
      post-operative pain. For older children the modified modified Faces Pain Scale (FPS-R) will
      be used. The 0-10 metric score is validated and reliable for children aged 4 - 16 years.

      Outcome measure Time Frame Parents will be asked to record the PPPM and either the FLACC or
      the FPS-R, twice daily for 14 days in a pain diary. The change in pain scores over 14 days
      will be evaluated.

      Preoperatively the severity of the SDB will be assessed, with the Snoring, Trouble Breathing,
      UnRefreshed (STBUR) questionnaire; a 5-item questionnaire.

      Primary Aim:

      1) To determine the severity and duration of postoperative pain after adenotonsillectomy
      (T&A) and to correlate the pain scores with the STBUR.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Otherwise healthy children aged 2 to 12 years I am not sure what the required sampling
        method means so I put non-probability sample.-
      
Keywords: Pain; Sleep Disordered Breathing