Sleep Breathing DisordersPhase 4NCT02205580
Continuous Intravenous Sufentanil Infusion for Postoperative Pain Management Following Tonsillectomy or Adeno-tonsillectomy in Children
A Phase 4 study testing continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusion, continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusion and continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusion in people with Sleep Breathing Disorders and Tonsillitis, run by Jin Ni at 1 site in China.
Trial summary
Postoperative pain following tonsillectomy or adeno-tonsillectomy in children is severe and sometimes last for days. Sufentanil is used by epidural route for postoperative analgesia in children. There are few reports about its use for postoperative analgesia by continuous intravenous infusion. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Sleep Breathing Disorders, Tonsillitis, Adenoid Hypertrophy
- What is being tested?
- continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusion, continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusion and continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Dec 2014
- 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologists grade I or II children aged 5-8 years undergoing coblation tonsillectomy or adeno-tonsillectomy as in-patient
Who cannot join
- Children with a history of adverse reaction to opioids, long-term use of opioid medications, and history of chronic pain.
- Psychiatric illness, kidney failure, hypotension, atrioventricular block, myasthenia gravis etc.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510623
About this study
Official title: Comparison of Three Different Rates of Continuous Intravenous Sufentanil Infusion for Postoperative Pain Management Following Coblation Tonsillectomy or Adeno-tonsillectomy in Children
Postoperative pain following tonsillectomy or adeno-tonsillectomy in children is severe and sometimes last for days. Sufentanil is used by epidural route for postoperative analgesia in children. There are few reports about its use for postoperative analgesia by continuous intravenous infusion. Its complications include , hypoxia, sedation, pruritus ,nausea and/or vomiting.
The investigators design this protocol to test efficacy of analgesia of three different rates of continuous intravenous sufentanil infusion for postoperative pain management following coblation tonsillectomy or adeno-tonsillectomy in children. The investigators also compare incidence rate of complications for three groups.
- Conditions
- Sleep Breathing Disorders, Tonsillitis, Adenoid Hypertrophy
- Being tested
- continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusion, continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusion, continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusion
- Medical subject headings
- Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusionDrug
continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusionDrug
continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusionDrug
| Study group | Role | What they receive |
|---|---|---|
| Sufentanil infusion rate 0.02μg•kg-1•h-1 | Experimental | Sufentanil infusion rate 0.02μg•kg-1•h-1 lasted for 48 hours Receives: Drug: continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusion |
| Sufentanil infusion rate 0.03μg•kg-1•h-1 | Experimental | Sufentanil infusion rate 0.03μg•kg-1•h-1 lasted for 48 hours Receives: Drug: continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusion |
| Sufentanil infusion rate 0.04μg•kg-1•h-1 | Experimental | Sufentanil infusion rate 0.04μg•kg-1•h-1 lasted for 48 hours Receives: Drug: continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective pain score
Measured: up to 48 hours after operation
Secondary outcomes (1)
incidence rate of hypoxia
Measured: 4h,8h,24h,48h after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Breathing DisordersStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jin Ni
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jin Ni, Guangzhou Women and Children's Medical Center
- Investigators
- Jin Ni, M.D., Principal investigator, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205580
- Sponsor's protocol ID
- GZWCMC
- Status last verified
- Sep 2014
- First submitted
- 26 Jul 2014
- Last updated
- 30 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Different Rates of Continuous Intravenous Sufentanil Infusion for Postoperative Pain Management Following Coblation Tonsillectomy or Adeno-tonsillectomy in Children
- ClinicalTrials.gov ID
- NCT02205580
- Acronym / sponsor ID
- GZWCMC
- Conditions
- Sleep Breathing Disorders, Tonsillitis, Adenoid Hypertrophy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jin NiUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 31 Jul 2014 (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.
Postoperative pain following tonsillectomy or adeno-tonsillectomy in children is severe and sometimes last for days. Sufentanil is used by epidural route for postoperative analgesia in children. There are few reports about its use for postoperative analgesia by continuous intravenous infusion. Its complications include , hypoxia, sedation, pruritus ,nausea and/or vomiting.
The investigators design this protocol to test efficacy of analgesia of three different rates of continuous intravenous sufentanil infusion for postoperative pain management following coblation tonsillectomy or adeno-tonsillectomy in children. The investigators also compare incidence rate of complications for three groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sufentanil infusion rate 0.02μg•kg-1•h-1 | Experimental | Drug: continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusionSufentanil infusion rate 0.02μg•kg-1•h-1 lasted for 48 hours |
| Sufentanil infusion rate 0.03μg•kg-1•h-1 | Experimental | Drug: continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusionSufentanil infusion rate 0.03μg•kg-1•h-1 lasted for 48 hours |
| Sufentanil infusion rate 0.04μg•kg-1•h-1 | Experimental | Drug: continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusionSufentanil infusion rate 0.04μg•kg-1•h-1 lasted for 48 hours |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists grade I or II children aged 5-8 years undergoing coblation tonsillectomy or adeno-tonsillectomy as in-patient
Key exclusion criteria (2 listed)
- Children with a history of adverse reaction to opioids, long-term use of opioid medications, and history of chronic pain.
- Psychiatric illness, kidney failure, hypotension, atrioventricular block, myasthenia gravis etc.
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 |
|---|---|---|
| continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusion | Drug | Sufentanil infusion rate 0.02μg•kg-1•h-1 |
| continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusion | Drug | Sufentanil infusion rate 0.03μg•kg-1•h-1 |
| continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusion | Drug | Sufentanil infusion rate 0.04μg•kg-1•h-1 |
Primary outcome
objective pain score
Time frame: up to 48 hours after operation
1 secondary outcome
incidence rate of hypoxia
Time frame: 4h,8h,24h,48h after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2014.
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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.
Jin Ni, M.D. principal investigator
Guangzhou Women and Children's Medical Center
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 continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusion, continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusion and continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusion in people with Sleep Breathing Disorders and Tonsillitis, run by Jin Ni at 1 site in China.
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 2 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 30 Sep 2014. 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 China. 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?
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?
objective pain score (time frame: up to 48 hours after operation). 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 30 Sep 2014.