Sleep ApneaNCT03378830
Pain at Home After Tonsillectomy With or Without Adenoidectomy
An observational study of Sleep Apnea and Adenotonsillectomy, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Sleep Apnea, Adenotonsillectomy, Pediatric ALL
- How many people
- 319 participants
- Where
- 1 siteCanada
- Study dates
- 19 Dec 2017to 1 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
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.-
Who may be able to join
- Elective scheduled surgery for adenotonsillectomy
- Fluency in French
- Fluency in English
Who cannot join
- Neuromuscular disease
- Seizure disorders,
- Cyanotic heart disease,
- Trisomy 21,
- Craniofacial syndromes such as Crouzons syndrome,
- Steroid dependant asthma,
Show all 10Show fewer
- Cystic fibrosis,
- Bronchopulmonary dysplasia
- Severe autism .
- Developmental delay which impair the assessment of pain.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- To determine the severity and duration of postoperative pain after adenotonsillectomy (T\&A) and to correlate the pain scores with the STBUR.
- Conditions
- Sleep Apnea, Adenotonsillectomy, Pediatric ALL
- Keywords
- Pain, Sleep Disordered Breathing
- Medical subject headings
- Sleep Apnea Syndromes, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Parent Pain Measure (PPPM)
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.
Measured: We are asking the parents to record the PPPM twice daily for 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start19 Dec 2017
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Brown, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Karen Brown, MD, Principal investigator, Pediatric Anesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378830
- Sponsor's protocol ID
- 2017-3127
- Status last verified
- Aug 2019
- First submitted
- 14 Dec 2017
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frigon C, Agnihotram RV, Berard-Giasson A, Lamonde F, Pang M, Daniel SJ, Brown KA. Association between obstructive sleep-disordered breathing severity and pain trajectories after adenotonsillectomy in children: a prospective cohort study. Br J Anaesth. 2026 Jan;136(1):167-178. doi: 10.1016/j.bja.2025.09.015. Epub 2025 Nov 28.
PubMed 41314942Lima LACN, Otis A, Balram S, Giasson AB, Carnevale FA, Frigon C, Brown KA. Parents' perspective on recovery at home following adenotonsillectomy: a prospective single-centre qualitative analysis. Can J Anaesth. 2023 Jul;70(7):1202-1215. doi: 10.1007/s12630-023-02479-2. Epub 2023 May 9.
PubMed 37160822
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain at Home After Tonsillectomy With or Without Adenoidectomy
- ClinicalTrials.gov ID
- NCT03378830
- Acronym / sponsor ID
- 2017-3127
- Conditions
- Sleep Apnea, Adenotonsillectomy, Pediatric ALL
- Keywords
- Pain, Sleep Disordered Breathing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 19 Dec 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 20 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the severity and duration of postoperative pain after adenotonsillectomy (T\&A) and to correlate the pain scores with the STBUR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.-
Key inclusion criteria (3 listed)
- Elective scheduled surgery for adenotonsillectomy
- Fluency in French
- Fluency in English
Key exclusion criteria (10 listed)
- Neuromuscular disease
- Seizure disorders,
- Cyanotic heart disease,
- Trisomy 21,
- Craniofacial syndromes such as Crouzons syndrome,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Derived from this study: PubMed 41314942Frigon C, Agnihotram RV, Berard-Giasson A, Lamonde F, Pang M, Daniel SJ, Brown KA. Association between obstructive sleep-disordered breathing severity and pain trajectories after adenotonsillectomy in children: a prospective cohort study. Br J Anaesth. 2026 Jan;136(1):167-178. doi: 10.1016/j.bja.2025.09.015. Epub 2025 Nov 28.
- Derived from this study: PubMed 37160822Lima LACN, Otis A, Balram S, Giasson AB, Carnevale FA, Frigon C, Brown KA. Parents' perspective on recovery at home following adenotonsillectomy: a prospective single-centre qualitative analysis. Can J Anaesth. 2023 Jul;70(7):1202-1215. doi: 10.1007/s12630-023-02479-2. Epub 2023 May 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Brown, MD principal investigator
Pediatric Anesthesiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea and Adenotonsillectomy, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Parent Pain Measure (PPPM) (time frame: We are asking the parents to record the PPPM twice daily for 14 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03378830, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019; AzTrials last refreshed its copy on 6 Nov 2026.