Postoperative PainNCT03639012
Outcomes of Carbohydrate Loading Paediatric Patients Preoperatively for Tonsillectomy and Adenoidectomy
A study testing Carbohydrate drink in people with Postoperative Pain and Postoperative Nausea, run by Jessica Gray at 1 site in Canada.
Trial summary
Randomised control trial of 150 paediatric patients aged between 3-8years. One group will receive a preoperative carbohydrate oral drink and the other group will receive current standard care (no drink) prior to undergoing tonsillectomy and/or adenoidectomy. Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Postoperative Nausea, Satisfaction
- What is being tested?
- Carbohydrate drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2018to Jun 2020
- Phase
- Interventional
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Undergoing Tonsillectomy and/or adenoidectomy
- consented to undertake preop carbohydrate drink and follow up procedures
Who cannot join
- Increased risk of aspiration or unable to swallow liquids
- outside age range
- non-consent to undertake treatment or follow up
Trial locations and contacts
1 site in 1 country.
Canada1 site
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Jessica A Gray, MBBS, 9024733721 ext. 3721, jessica.gray@iwk.nshealth.ca
Ashley Zahavich, 9024733015, ashley.zahavich@nshealth.ca
About this study
Official title: Observational Outcomes in Paediatric Patients Who Receive Preoperative Carbohydrate Loading for Adenoidectomy and Tonsillectomy, a Randomised Control Trial
Randomised control trial of 150 paediatric patients aged between 3-8years. One group will receive a preoperative carbohydrate oral drink and the other group will receive current standard care (no drink) prior to undergoing tonsillectomy and/or adenoidectomy.
Outcomes to be reported will be: 1) patient and parent satisfaction; 2) post operative pain score at: recover, 1 hour post op, prior to discharge home and then day 1 postoperatively; 3) PONV rates in recovery, prior to discharge home and again on Day 1 postoperatively; 4) sleep quality night after surgery.
Read the detailed description
Children undergoing tonsillectomy and/or adenoidectomy will be consented via parents prior to the day of surgery and then randomised to 1 of 2 groups who will either receive the intervention or current standard care. Patients will be recruited from the ENT outpatient clinics in conjunction with the ENT surgeons.
Data collection will be undertaken with the aid of experience research assistants.
- Conditions
- Postoperative Pain, Postoperative Nausea, Satisfaction, Sleep, Postoperative Complications
- Being tested
- Carbohydrate drink
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting, Personal Satisfaction, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate drinkDietary supplement
Children randomised to this group will receive a preoperative carbohydrate drink 90-120mins prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate loading | Active comparator | Patients to receive an oral preoperative carbohydrate drink Receives: Dietary Supplement: Carbohydrate drink |
| No Carbohydrate loading | No intervention | Current standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score
Visual analogue scale (0-5)
Measured: day 1 postoperatively
Secondary outcomes (3)
Patient and parent satisfaction
Questionnaire: regarding how satisfied parents/ patients were with the treatment (satisfied or unsatisfied)
Measured: Day 1 postoperatively
Quality of sleep
Questionnaire: (scale Child slept very well, average night sleep, poor nights sleep)
Measured: Day 1 post operative
Postoperative Nausea and Vomiting
Questionnaire: vomiting, felt very nauseated, some nausea, none
Measured: 4 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study startSep 2018 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised control trial into 1 of 2 groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jessica Gray
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jessica Gray, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639012
- Sponsor's protocol ID
- Paeds ERAS for T&A
- Status last verified
- Aug 2018
- First submitted
- 11 Jul 2018
- Last updated
- 21 Aug 2018
- 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 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Outcomes in Paediatric Patients Who Receive Preoperative Carbohydrate Loading for Adenoidectomy and Tonsillectomy, a Randomised Control Trial
- ClinicalTrials.gov ID
- NCT03639012
- Acronym / sponsor ID
- Paeds ERAS for T&A
- Conditions
- Postoperative Pain, Postoperative Nausea, Satisfaction, Sleep, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Jessica GrayUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 20 Aug 2018 (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.
Randomised control trial of 150 paediatric patients aged between 3-8years. One group will receive a preoperative carbohydrate oral drink and the other group will receive current standard care (no drink) prior to undergoing tonsillectomy and/or adenoidectomy.
Outcomes to be reported will be: 1) patient and parent satisfaction; 2) post operative pain score at: recover, 1 hour post op, prior to discharge home and then day 1 postoperatively; 3) PONV rates in recovery, prior to discharge home and again on Day 1 postoperatively; 4) sleep quality night after surgery.
Detailed description
Children undergoing tonsillectomy and/or adenoidectomy will be consented via parents prior to the day of surgery and then randomised to 1 of 2 groups who will either receive the intervention or current standard care. Patients will be recruited from the ENT outpatient clinics in conjunction with the ENT surgeons.
Data collection will be undertaken with the aid of experience research assistants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised control trial into 1 of 2 groups
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate loading | Active comparator | Dietary Supplement: Carbohydrate drinkPatients to receive an oral preoperative carbohydrate drink |
| No Carbohydrate loading | No intervention | –Current standard of care |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Undergoing Tonsillectomy and/or adenoidectomy
- consented to undertake preop carbohydrate drink and follow up procedures
Key exclusion criteria (3 listed)
- Increased risk of aspiration or unable to swallow liquids
- outside age range
- non-consent to undertake treatment or follow up
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 |
|---|---|---|
| Carbohydrate drinkChildren randomised to this group will receive a preoperative carbohydrate drink 90-120mins prior to surgery | Dietary supplement | Carbohydrate loading |
Primary outcome
Postoperative Pain Score
Time frame: day 1 postoperatively
Visual analogue scale (0-5)
3 secondary outcomes
Patient and parent satisfaction
Time frame: Day 1 postoperatively
Quality of sleep
Time frame: Day 1 post operative
Postoperative Nausea and Vomiting
Time frame: 4 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate drink in people with Postoperative Pain and Postoperative Nausea, run by Jessica Gray 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 2 inclusion and 3 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 21 Aug 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica A Gray, MBBS, M.Med (9024733721 ext. 3721, jessica.gray@iwk.nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Score (time frame: day 1 postoperatively). 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 21 Aug 2018.