Pain, PostoperativeNCT04349397
Use of Analgesics and Pain Scores After Pediatric Adenotonsillectomy
An observational study of Pain, Postoperative and Obstructive Sleep Apnea of Child, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of the study is to quantify the use of pain medications given to children aged 3 - 12 years as well as their pain level through pain scores after they have undergone a tonsillectomy or adenotonsillectomy surgery at Doernbecher Children's Hospital (DCH). Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Pain, Postoperative, Obstructive Sleep Apnea of Child
- What is being tested?
- Medication Tracking Form
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to Jun 2021
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: 1. Parent or guardian refusal of consent 2. Child has severe OSA (Apnea-Hypopnea Index (AHI) ≥10 or O2 Saturation <85% on polysomnogram) 3. Child with behavioral disorders (ADHD, ASD, etc.) 4. Child with genetic disorders (down syndrome, mucopolysaccharidoses, achondroplasia, Prader-Willi syndrome, etc.) 5. Child with neuromuscular disorders (muscular dystrophy, hypotonia, etc.) 6. Child with a history of extremely preterm (born at <28 weeks) or very preterm (born at 28-32 weeks) 7. Child with moderate to severe developmental delay 8. Child is obese (BMI ≥ 95th percentile) 9. Child with craniofacial anomalies (retrognathia, micrognathia, midface hypoplasia) 10. Child with allergies to acetaminophen, ibuprofen, morphine, fentanyl or oxycodone
Who may be able to join
- Child aged 3-12 that is scheduled to undergo tonsillectomy or adenotonsillectomy, with or without ear tubes or Parent or guardian of a child aged 3-12 years old that is scheduled to undergo tonsillectomy or adenotonsillectomy, with or without ear tubes
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
About this study
The purpose of the study is to quantify the use of pain medications given to children aged 3 - 12 years as well as their pain level through pain scores after they have undergone a tonsillectomy or adenotonsillectomy surgery at Doernbecher Children's Hospital (DCH). We would like to learn more about the pain medications given and the pain scores of children post-surgery for the first 5 days following discharge from the hospital.
Read the detailed description
You and your child will be enrolled into the study during your child's scheduled surgery at DCH. Your child's surgery, anesthesia plan, and recovery will not change because of your participation in this study. Following discharge from the hospital, the study team will give you two follow-up phone calls that will take approximately 15 minutes. During these phone calls, we will ask you about your child's pain, any nausea or vomiting that has occurred, your child's intake of liquid and food, your child's activity level, and the medications they have been given over the course of the 5 days post-operation. Along with talking over the phone, we will ask you to document this information. After the post-operation day 6 phone call, you and your child will not be asked any additional questions for research purposes and we will ask you to return any documents you were given by the study team. Within 30 days of your and your child's participation in the study, the research team will pull medical information from your child's electronic medical record. Your child's electronic medical record will be reviewed to obtain demographic information such as date of birth, age, weight, ethnicity, medical history, and status information will also be collected such as allergies, potential complications, any pain scores collected during your child's post-anesthesia care unit (PACU) stay, and medical visits. 30 days after your child's surgery, you and your child will no longer be enrolled in this research study.
- Being tested
- Medication Tracking Form
- Keywords
- tonsillectomy, adenotonsillectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Tracking FormBehavioural
Parents will complete medication tracking form for 5 days after child's surgery. They will track medications administered, pain scores, nausea and vomiting
| Study group | Role | What they receive |
|---|---|---|
| Pediatric tonsillectomy patients | All patients enrolled into study prior to undergoing tonsillectomy or adenotonsillectomy Receives: Behavioral: Medication Tracking Form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid administered during POD 1-5 (converted to morphine dose equivalents)
Total amount of opioid analgesics administered at home on Post-operative days 1-5.
Measured: POD 1-5
Secondary outcomes (7)
Mean Worst Pain Scores POD 1-5
Average of worst pain scores as documented twice a day on POD 1-5
Measured: POD 1-5
Total acetaminophen administered on POD 1-5
Total acetaminophen given (total dose and total quantity as mg/kg)
Measured: POD 1-5
Total ibuprofen administered on POD 1-5
Total ibuprofen given (total dose and total quantity as mg/kg)
Measured: POD 1-5
Frequency of Vomiting on POD 1-5
Number of days vomiting on POD 1-5
Measured: POD 1-5
Duration of impaired drinking
Return to normal drinking on POD 1-5
Measured: POD 1-5
Duration of impaired eating
Return to normal eating on POD 1-5
Measured: POD 1-5
Duration of impaired activity
Return to normal activity on POD 1-5
Measured: POD 1-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Aug 2019
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Martin, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349397
- Sponsor's protocol ID
- 19199
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2020
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Analgesics and Pain Scores After Pediatric Adenotonsillectomy
- ClinicalTrials.gov ID
- NCT04349397
- Acronym / sponsor ID
- 19199
- Keywords
- tonsillectomy, adenotonsillectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 16 Apr 2020 (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 purpose of the study is to quantify the use of pain medications given to children aged 3 - 12 years as well as their pain level through pain scores after they have undergone a tonsillectomy or adenotonsillectomy surgery at Doernbecher Children's Hospital (DCH). We would like to learn more about the pain medications given and the pain scores of children post-surgery for the first 5 days following discharge from the hospital.
Detailed description
You and your child will be enrolled into the study during your child's scheduled surgery at DCH. Your child's surgery, anesthesia plan, and recovery will not change because of your participation in this study. Following discharge from the hospital, the study team will give you two follow-up phone calls that will take approximately 15 minutes. During these phone calls, we will ask you about your child's pain, any nausea or vomiting that has occurred, your child's intake of liquid and food, your child's activity level, and the medications they have been given over the course of the 5 days post-operation. Along with talking over the phone, we will ask you to document this information. After the post-operation day 6 phone call, you and your child will not be asked any additional questions for research purposes and we will ask you to return any documents you were given by the study team. Within 30 days of your and your child's participation in the study, the research team will pull medical information from your child's electronic medical record. Your child's electronic medical record will be reviewed to obtain demographic information such as date of birth, age, weight, ethnicity, medical history, and status information will also be collected such as allergies, potential complications, any pain scores collected during your child's post-anesthesia care unit (PACU) stay, and medical visits. 30 days after your child's surgery, you and your child will no longer be enrolled in this research study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric tonsillectomy patients | – | Behavioral: Medication Tracking FormAll patients enrolled into study prior to undergoing tonsillectomy or adenotonsillectomy |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 1. Parent or guardian refusal of consent 2. Child has severe OSA (Apnea-Hypopnea Index (AHI) ≥10 or O2 Saturation <85% on polysomnogram) 3. Child with behavioral disorders (ADHD, ASD, etc.) 4. Child with genetic disorders (down syndrome, mucopolysaccharidoses, achondroplasia, Prader-Willi syndrome, etc.) 5. Child with neuromuscular disorders (muscular dystrophy, hypotonia, etc.) 6. Child with a history of extremely preterm (born at <28 weeks) or very preterm (born at 28-32 weeks) 7. Child with moderate to severe developmental delay 8. Child is obese (BMI ≥ 95th percentile) 9. Child with craniofacial anomalies (retrognathia, micrognathia, midface hypoplasia) 10. Child with allergies to acetaminophen, ibuprofen, morphine, fentanyl or oxycodone
Key inclusion criteria (1 listed)
- Child aged 3-12 that is scheduled to undergo tonsillectomy or adenotonsillectomy, with or without ear tubes or Parent or guardian of a child aged 3-12 years old that is scheduled to undergo tonsillectomy or adenotonsillectomy, with or without ear tubes
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication Tracking FormParents will complete medication tracking form for 5 days after child's surgery. They will track medications administered, pain scores, nausea and vomiting | Behavioural | Pediatric tonsillectomy patients |
Primary outcome
Total opioid administered during POD 1-5 (converted to morphine dose equivalents)
Time frame: POD 1-5
Total amount of opioid analgesics administered at home on Post-operative days 1-5.
7 secondary outcomes
Mean Worst Pain Scores POD 1-5
Time frame: POD 1-5
Total acetaminophen administered on POD 1-5
Time frame: POD 1-5
Total ibuprofen administered on POD 1-5
Time frame: POD 1-5
Frequency of Vomiting on POD 1-5
Time frame: POD 1-5
Duration of impaired drinking
Time frame: POD 1-5
Duration of impaired eating
Time frame: POD 1-5
Duration of impaired activity
Time frame: POD 1-5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pain, Postoperative and Obstructive Sleep Apnea of Child, run by Oregon Health and Science University at 1 site in United States.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Apr 2020. 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 United States. 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?
Results are not available in the source record.
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?
Total opioid administered during POD 1-5 (converted to morphine dose equivalents) (time frame: POD 1-5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2020.