Pediatric AdenotonsillectomyPhase 4NCT01057381
Dexmedetomidine in Pediatric Tonsillectomy
A Phase 4 study testing Dexmedetomidine 0.75 mcg/kg, Morphine 50 mcg/kg and Morphine 100 mcg/kg in people with Pediatric Adenotonsillectomy and Post Operative Analgesia, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The hypothesis of this study is that the administration of an intra-operative dose of dexmedetomidine will result in adequate analgesia without respiratory depression thereby resulting in an early discharge from the post anesthetic care unit following adenotonsillectomy. Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Adenotonsillectomy, Post Operative Analgesia
- What is being tested?
- Dexmedetomidine 0.75 mcg/kg, Morphine 50 mcg/kg and Morphine 100 mcg/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Dec 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between ages 3 and 17 years with American Society of Anesthesiology classification 1 or 2.
Who cannot join
- Children less than 3 years
- Children with uncorrected cardiac lesions
- Children with heart block or liver impairment
- Children with American Society of Anesthesiology Class 3 or 4.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Children's Hospital, Baylor College of Medicine
Houston, Texas, 77030
About this study
Official title: Dose Response Relationship of Dexmedetomidine in Decreasing Post Operative Analgesic Requirements in the Pediatric Tonsillectomy Patient
The hypothesis of this study is that the administration of an intra-operative dose of dexmedetomidine will result in adequate analgesia without respiratory depression thereby resulting in an early discharge from the post anesthetic care unit following adenotonsillectomy.
Read the detailed description
Dexmedetomidine, an alpha 2 agonist provides some analgesia without respiratory depression. Children undergoing tonsillectomy and adenoidectomy occasionally have episodes of respiratory obstruction in the recovery room following administration of opioids.
As dexmedetomidine provides some analgesia without respiratory depression,an intra-operative dose of dexmedetomidine may provide adequate analgesia without significant side effects thereby allowing for quick post operative recovery.
- Being tested
- Dexmedetomidine 0.75 mcg/kg, Morphine 50 mcg/kg, Morphine 100 mcg/kg, Dexmedetomidine 1 mcg/kg
- Keywords
- Adenotonsillectomy, Postoperative analgesia, Pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine 0.75 mcg/kgDrug
Also called Precedex
Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia.
Morphine 50 mcg/kgDrug
Also called Morphine
Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia
Morphine 100 mcg/kgDrug
Also called Morphine
Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia
Dexmedetomidine 1 mcg/kgDrug
Also called Precedex
Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine 0.75 mcg/kg | Active comparator | Intraoperative administration for analgesia. Receives: Drug: Dexmedetomidine 0.75 mcg/kg |
| Dexmedetomidine 1mcg/kg | Active comparator | Intra-operative administration of dexmedetomidine 1 mcg/kg for analgesia Receives: Drug: Dexmedetomidine 1 mcg/kg |
| Morphine 50 mcg/kg | Active comparator | Intra-operative administration of morphine 50 mcg/kg for analgesia Receives: Drug: Morphine 50 mcg/kg |
| Morphine 100mcg/kg | Active comparator | Intra-operative administration of morphine 100mcg/kg for analgesia Receives: Drug: Morphine 100 mcg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Post-Operative Rescue Morphine Required for Analgesia
Measured: From admission to discharge from PACU, up to 1 hour
Secondary outcomes (5)
Morphine Rescue Doses Needed by Participants
Subjects with a Children's Hospital of Eastern Ontario Pain Scale score greater than 8 received rescue morphine doses of 25 ug/kg IV at 10-minute intervals until the score was less than 8.
Minimum and Maximum values: minimum score: 4 \& maximum score: 13. The higher the score ( > 8), the greater the pain appreciated by the patient.
Measured: From admission to discharge from PACU, up to 1 hour
Duration of Oxygen Supplementation
The subjects were then transported to the PACU with supplemental oxygen. Oxygen administration was continued after extubation until the patient was awake and could sustain room air saturations greater than 95% for 5 minutes. Duration of oxygen requirement was recorded as the time from tracheal extubation to cessation of oxygen supplementation in the PACU.
Measured: From admission to PACU until room air saturations greater than or equal to 95% for 5 minutes
Time to PACU Discharge Readiness
Patients were considered ready for discharge from the PACU when they attained an Aldrete score of 9 or more and were free from pain, nausea, and vomiting. Aldrete score ranges form 0 to 10 and patients greater than 8 are deemed satisfactory for discharge from the PACU
Measured: From admission to discharge from PACU, no time limit
Number of Participants With Emergence Agitation
Patients in the PACU who were crying, restless, disoriented, unresponsive to the parent's voice, with non-purposeful thrashing movements requiring additional personnel to prevent bodily harm, and inconsolable even after parental presence, rescue analgesia and additional measures of comfort were considered to have emergence agitation.
Measured: From admission to discharge from PACU, no time limit
Number of Participants With Postoperative Complications
Post-operative complications including emesis, prolonged oxygen requirement or post- tonsillectomy bleed assessed up to 1 hour in PACU
Measured: From admission to discharge from PACU, up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startAug 2005
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric AdenotonsillectomyStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olutoyin A. Olutoye, Baylor College of Medicine
- Investigators
- Olutoyin A Olutoye, M.D., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057381
- Sponsor's protocol ID
- H-17558
- Status last verified
- Jul 2021
- First submitted
- 25 Jan 2010
- Last updated
- 27 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response Relationship of Dexmedetomidine in Decreasing Post Operative Analgesic Requirements in the Pediatric Tonsillectomy Patient
- ClinicalTrials.gov ID
- NCT01057381
- Acronym / sponsor ID
- H-17558
- Keywords
- Adenotonsillectomy, Postoperative analgesia, Pediatrics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Jan 2010 (estimated)
- Results
- Posted 1 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of this study is that the administration of an intra-operative dose of dexmedetomidine will result in adequate analgesia without respiratory depression thereby resulting in an early discharge from the post anesthetic care unit following adenotonsillectomy.
Detailed description
Dexmedetomidine, an alpha 2 agonist provides some analgesia without respiratory depression. Children undergoing tonsillectomy and adenoidectomy occasionally have episodes of respiratory obstruction in the recovery room following administration of opioids.
As dexmedetomidine provides some analgesia without respiratory depression,an intra-operative dose of dexmedetomidine may provide adequate analgesia without significant side effects thereby allowing for quick post operative recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine 0.75 mcg/kg | Active comparator | Drug: Dexmedetomidine 0.75 mcg/kgIntraoperative administration for analgesia. |
| Dexmedetomidine 1mcg/kg | Active comparator | Drug: Dexmedetomidine 1 mcg/kgIntra-operative administration of dexmedetomidine 1 mcg/kg for analgesia |
| Morphine 50 mcg/kg | Active comparator | Drug: Morphine 50 mcg/kgIntra-operative administration of morphine 50 mcg/kg for analgesia |
| Morphine 100mcg/kg | Active comparator | Drug: Morphine 100 mcg/kgIntra-operative administration of morphine 100mcg/kg for analgesia |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between ages 3 and 17 years with American Society of Anesthesiology classification 1 or 2.
Key exclusion criteria (4 listed)
- Children less than 3 years
- Children with uncorrected cardiac lesions
- Children with heart block or liver impairment
- Children with American Society of Anesthesiology Class 3 or 4.
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 |
|---|---|---|
| Dexmedetomidine 0.75 mcg/kgAlso: PrecedexSingle intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia. | Drug | Dexmedetomidine 0.75 mcg/kg |
| Morphine 50 mcg/kgAlso: MorphineSingle intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia | Drug | Morphine 50 mcg/kg |
| Morphine 100 mcg/kgAlso: MorphineSingle intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia | Drug | Morphine 100mcg/kg |
| Dexmedetomidine 1 mcg/kgAlso: PrecedexSingle intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia | Drug | Dexmedetomidine 1mcg/kg |
Primary outcome
Amount of Post-Operative Rescue Morphine Required for Analgesia
Time frame: From admission to discharge from PACU, up to 1 hour
5 secondary outcomes
Morphine Rescue Doses Needed by Participants
Time frame: From admission to discharge from PACU, up to 1 hour
Duration of Oxygen Supplementation
Time frame: From admission to PACU until room air saturations greater than or equal to 95% for 5 minutes
Time to PACU Discharge Readiness
Time frame: From admission to discharge from PACU, no time limit
Number of Participants With Emergence Agitation
Time frame: From admission to discharge from PACU, no time limit
Number of Participants With Postoperative Complications
Time frame: From admission to discharge from PACU, up to 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Olutoyin A Olutoye, M.D. principal investigator
Baylor College of Medicine
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 Dexmedetomidine 0.75 mcg/kg, Morphine 50 mcg/kg and Morphine 100 mcg/kg in people with Pediatric Adenotonsillectomy and Post Operative Analgesia, run by Baylor College of Medicine 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 4 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 27 Jul 2021. 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.
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?
Yes. Results are posted in the registry (first posted 1 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Amount of Post-Operative Rescue Morphine Required for Analgesia (time frame: From admission to discharge from PACU, up to 1 hour). 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 27 Jul 2021.