Pain at Home After Tonsillectomy With or Without Adenoidectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03378830
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : December 22, 2017
Information provided by (Responsible Party):
Karen Brown, McGill University Health Center

Brief 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.

Condition or disease
Sleep Apnea Adenotonsillectomy Pediatric ALL

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.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pain at Home After Tonsillectomy With or Without Adenoidectomy
Actual Study Start Date : December 19, 2017
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids Tonsillitis

Primary Outcome Measures :
  1. Postoperative Parent Pain Measure (PPPM) [ Time Frame: We are asking the parents to record the PPPM twice daily for 14 days. ]
    The PPPM is a validated 15 item questionnaire that requires a Yes or No response. The maximum total score is 15. A total score above 6 indicates clinically relevant pain.

Other Outcome Measures:
  1. The STBUR (Snoring, Trouble Breathing, UnRefreshed) questionnaire. [ Time Frame: The STBUR will be administered once during the preoperative evaluation of the child. ]
    The STBUR is a 5 item questionnaire that requires a yes or no response. The STBUR has been validated to predict 1) perioperative respiratory adverse events and 2) opioid related respiratory adverse event. The maximum score is 5. A total score of 3 or more is associated with in increased risk of respiratory adverse events.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.-

Inclusion Criteria:

  • Elective scheduled surgery for adenotonsillectomy
  • Fluency in French
  • Fluency in English

Exclusion Criteria:

  • Neuromuscular disease
  • Seizure disorders,
  • Cyanotic heart disease,
  • Trisomy 21,
  • Craniofacial syndromes such as Crouzons syndrome,
  • Steroid dependant asthma,
  • Cystic fibrosis,
  • Bronchopulmonary dysplasia
  • Severe autism .
  • Developmental delay which impair the assessment of pain.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03378830

Contact: Cindy Intini 514 934 1934 ext 71457
Contact: Suzie Gougeon

Canada, Quebec
The Montreal Children's Hospital Recruiting
Montréal, Quebec, Canada, H4A 3J1
Contact: Karen Brown, MD    514 412 4400 ext 24888   
Contact: Roula Cacolyris    514 412 4400 ext 22464   
Sponsors and Collaborators
McGill University Health Center
Principal Investigator: Karen Brown, MD Pediatric Anesthesiologist

Responsible Party: Karen Brown, MD, McGill University Health Center Identifier: NCT03378830     History of Changes
Other Study ID Numbers: 2017-3127
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karen Brown, McGill University Health Center:
Sleep Disordered Breathing