Pediatric Post-tonsillectomy PainPhase 4NCT02793011
Dexamethasone and Post-tonsillectomy Pain in Children
A Phase 4 study testing Dexamethasone in people with Pediatric Post-tonsillectomy Pain, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
The investigators will use a prospective randomized, controlled design utilizing a single preoperative dose of oral dexamethasone or placebo to achieve these specific aims: Specific Aim 1: To evaluate the potential for a single preoperative dose of oral dexamethasone administered the night before surgery to reduce the… Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Pediatric Post-tonsillectomy Pain
- What is being tested?
- Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 27 Jun 2019
- Phase
- Phase 4
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Scheduled for tonsillectomy and/or adenoidectomy at University of Michigan, C. S. Mott Children's Hospital
Who cannot join
- Known hypersensitivity to dexamethasone
- Developmental delay
- Taking chronic analgesics
- Taking chronic systemic steroids
- Treatment with steroids in last 30 days
- Cushings or Prader-Willi or Nephrotic Syndromes
- Diabetes Mellitus
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: Does Dexamethasone Reduce Postoperative Pain in Pediatric Tonsillectomy Patients?
The investigators will use a prospective randomized, controlled design utilizing a single preoperative dose of oral dexamethasone or placebo to achieve these specific aims:
- Specific Aim 1: To evaluate the potential for a single preoperative dose of oral dexamethasone administered the night before surgery to reduce the incidence and severity of early post tonsillectomy pain (PTP) in children
- Specific Aim 2: To prospectively evaluate differences in early PTP experience between overweight/obese children and their lean peers.
- Specific Aim 3: To determine whether circulating inflammatory markers are strongly linked to PTP severity in children and whether they could be potential contributors to the higher pain experienced by overweight/obese children following Tonsillectomy and or Adenoidectomy.
Read the detailed description
(See brief summary as well)
The study will serve as a vehicle for a three-pronged approach (clinical observation, biological basis and therapeutic intervention) reflects the applicants professional interest in translational pediatric obesity research If the investigators find that BMI-dependent disparity exists in Post Tonsillectomy Pain (PTP) and that preoperative down regulation of inflammatory response with one preoperative dose of corticosteroids reduces PTP, our findings should ultimately lead to improved postoperative pain management of pediatric PTP especially in obese children.
- Conditions
- Pediatric Post-tonsillectomy Pain
- Being tested
- Dexamethasone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called corticosteroid
Oral dexamethasone elixir (0.5mg/ml or 4 mg/ml) mixed with Ora-sweet or simple syrup to mask the taste. Or 1 mg or 4 mg dexamethasone capsules if age appropriate
PlaceboDrug
Placebo liquid (Ora-sweet or simple syrup) or Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Liquid or capsule dexamethasone - to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy Receives: Drug: Dexamethasone |
| Placebo | Placebo comparator | Placebo liquid or capsule to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of moderate/severe pain(>/= 4 of 10 using the Wong-Baker faces Scale) during recovery room stay
Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit.
Measured: 0-8 hours postoperatively
Secondary outcomes (2)
Proportion of patients requiring analgesic intervention in the PACU will differ by BMI category (normal, overweight and obese).
Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit.
Measured: 0-8 hours postoperatively
Bivariate association between BMI (in Kg/m2) and serum values of inflammatory markers (CRP, TNF-alpha and IL-6) will be computed.
Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit.
Measured: 0-8 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion27 Jun 2019
- Study completion27 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Post-tonsillectomy PainStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Olubukola Nafiu, University of Michigan
- Investigators
- Olubukola Nafiu, MD, Principal investigator, University of Michigan, CS Mott Children's Hospital, Dept of Otolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793011
- Sponsor's protocol ID
- HUM00084860
- Other IDs
- 5K23GM104354
- Status last verified
- Sep 2020
- First submitted
- 10 May 2016
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Dexamethasone Reduce Postoperative Pain in Pediatric Tonsillectomy Patients?
- ClinicalTrials.gov ID
- NCT02793011
- Acronym / sponsor ID
- HUM00084860
- Conditions
- Pediatric Post-tonsillectomy Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- Jun 2016
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 8 Jun 2016 (estimated)
- 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 investigators will use a prospective randomized, controlled design utilizing a single preoperative dose of oral dexamethasone or placebo to achieve these specific aims:
- Specific Aim 1: To evaluate the potential for a single preoperative dose of oral dexamethasone administered the night before surgery to reduce the incidence and severity of early post tonsillectomy pain (PTP) in children
- Specific Aim 2: To prospectively evaluate differences in early PTP experience between overweight/obese children and their lean peers.
- Specific Aim 3: To determine whether circulating inflammatory markers are strongly linked to PTP severity in children and whether they could be potential contributors to the higher pain experienced by overweight/obese children following Tonsillectomy and or Adenoidectomy.
Detailed description
(See brief summary as well)
The study will serve as a vehicle for a three-pronged approach (clinical observation, biological basis and therapeutic intervention) reflects the applicants professional interest in translational pediatric obesity research If the investigators find that BMI-dependent disparity exists in Post Tonsillectomy Pain (PTP) and that preoperative down regulation of inflammatory response with one preoperative dose of corticosteroids reduces PTP, our findings should ultimately lead to improved postoperative pain management of pediatric PTP especially in obese children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: DexamethasoneLiquid or capsule dexamethasone - to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo liquid or capsule to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Scheduled for tonsillectomy and/or adenoidectomy at University of Michigan, C. S. Mott Children's Hospital
Key exclusion criteria (7 listed)
- Known hypersensitivity to dexamethasone
- Developmental delay
- Taking chronic analgesics
- Taking chronic systemic steroids
- Treatment with steroids in last 30 days
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 |
|---|---|---|
| DexamethasoneAlso: corticosteroidOral dexamethasone elixir (0.5mg/ml or 4 mg/ml) mixed with Ora-sweet or simple syrup to mask the taste. Or 1 mg or 4 mg dexamethasone capsules if age appropriate | Drug | Dexamethasone |
| PlaceboPlacebo liquid (Ora-sweet or simple syrup) or Placebo capsule | Drug | Placebo |
Primary outcome
Incidence of moderate/severe pain(>/= 4 of 10 using the Wong-Baker faces Scale) during recovery room stay
Time frame: 0-8 hours postoperatively
Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit.
2 secondary outcomes
Proportion of patients requiring analgesic intervention in the PACU will differ by BMI category (normal, overweight and obese).
Time frame: 0-8 hours postoperatively
Bivariate association between BMI (in Kg/m2) and serum values of inflammatory markers (CRP, TNF-alpha and IL-6) will be computed.
Time frame: 0-8 hours postoperatively
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 10 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Pediatric Post-tonsillectomy Pain
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Fasting Time and Post-tonsillectomy Pain
Tonsillar Disorder
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Sphenopalatine Ganglion Block for Pain Relief After Pediatric Adenotonsillectomy
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Topical Magnesium Sulfate Versus Peritonsillar Bupivacaine for Post-Tonsillectomy Pain Relief in Children
Post-tonsillectomy Pain, Tonsillectomy
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Metabolomic Profiling of Racial Disparity
Adenoid Hypertrophy, Tonsillar Hypertrophy
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.
Olubukola Nafiu, MD principal investigator
University of Michigan, CS Mott Children's Hospital, Dept of Otolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone in people with Pediatric Post-tonsillectomy Pain, run by Nationwide Children's Hospital 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 7 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 10 Sep 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of moderate/severe pain(>/= 4 of 10 using the Wong-Baker faces Scale) during recovery room stay (time frame: 0-8 hours 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 10 Sep 2020.