Respiration, ArtificialPhase 4NAPS PilotNCT00959062
Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children
A Phase 4 study testing clonidine in people with Respiration, Artificial and Critical Illness, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
Trial summary
Almost all critically ill children who are mechanically ventilated require sedation and analgesia. Providing effective sedation for children in the PICU requires careful balancing of the need for sedation with the adverse effects associated with sedative medications. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Respiration, Artificial, Critical Illness, Conscious Sedation
- What is being tested?
- clonidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2010to Sep 2012
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- aged 1 month to 18 years
- mechanically ventilated
- the attending physician expects to require mechanical ventilation for at least 2 more days
- requires sedation in the form of: morphine by continuous infusion or greater than 4 intermittent doses in the previous 24 hours or fentanyl as a continuous infusion AND midazolam or lorazepam by continuous infusion or more than 3 intermittent doses of lorazepam or 6 doses of midazolam in the previous 12 hours
- has enteral access (gastric or jejunal feeding tube)
Who cannot join
- hemodynamically unstable
- meet the American College of Critical Care Medicine hemodynamic definition of shock
- hypotensive or tachycardic
- bradycardia, hemodynamically significant cardiac disease or chronic use of anti-hypertensive or diuretic medications
- a traumatic brain injury on admission
- chronically (defined as routine administration prior to hospital admission or for greater than 7 days in hospital prior to PICU admission) use benzodiazepines or opioids
Show all 15Show fewer
- have received greater than two doses of clonidine within the previous 2 days or dexmedetomidine in the past 2 days
- were previously enrolled in this study
- are currently enrolled in a related study
- are known to be pregnant or breastfeeding
- are known to be allergic to clonidine or any other ingredient in the tablets or suspension
- are being considered for organ procurement
- were chronically (>30 days) ventilated prior to PICU admission
- are currently receiving, or are expected to initiate the ketogenic diet
- are receiving cyclosporine or methylphenidate
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McMaster Children's Hospital/Hamilton Health Sciences
Hamilton, Ontario, L8n 3Z5
London Health Sciences Centre
London, Ontario
About this study
Official title: New Approaches to Pediatric Sedation: Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children (NAPS Pilot Trial)
Almost all critically ill children who are mechanically ventilated require sedation and analgesia. Providing effective sedation for children in the PICU requires careful balancing of the need for sedation with the adverse effects associated with sedative medications. Clonidine is often used as an adjunctive sedative and analgesic in children but a well designed and adequately powered randomized trial is required to test the effect of clonidine-based sedation. Because there are no large randomized trials of sedation related interventions among critically ill children there are many unknown factors. This pilot trial, focussing on feasibility outcomes will assess the feasibility of, and inform the design of, a larger randomized controlled trial which will focus on clinically important outcomes.
Read the detailed description
Almost all critically ill children who are mechanically ventilated require sedation and analgesia. Providing effective sedation for children in the PICU requires careful balancing of the need for sedation with the adverse effects associated with sedative medications. Inadequate sedation may result in undue pain and suffering for children, ventilator dysynchrony and may risk removal of life sustaining devices. Excess sedation limits patients' interaction with their parents and care-givers and may result in delayed weaning from mechanical ventilation, prolonged PICU stay and the attendant risks of increased morbidity. Critically ill children may also experience withdrawal when these medications are stopped. Randomized trails in adults have shown that sedation related interventions can improve patients outcomes, but such trials have not been performed in children.
Clonidine is often used as an adjunctive sedative and analgesic in children but a well designed and adequately powered randomized trial is required to test the effect of clonidine-based sedation. Because there are no large randomized trials of sedation related interventions among critically ill children there are many unknown factors.
This pilot trial, focussing on feasibility outcomes will assess the feasibility of, and inform the design of, a larger randomized controlled trial which will focus on clinically important outcomes.
- Being tested
- clonidine, placebo
- Keywords
- Pilot Study, Randomized Controlled Trial, Critically Ill, Child, Pediatric, Clonidine, Sedation
- Medical subject headings
- Respiratory Aspiration, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clonidineDrug
5 mcg/kg (maximum 200 mcg) enterally every 6 hours
placeboDrug
Preparation visually identical to clonidine.
| Study group | Role | What they receive |
|---|---|---|
| clonidine | Experimental | Not described Receives: Drug: clonidine |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of screening procedures.
Measured: 90 days
Protocol adherence.
Measured: 90 days
Enrollment rate.
Measured: 90 days
Timeliness of drug administration.
Measured: 90 days
Secondary outcomes (5)
Sedation and analgesia requirements.
Measured: 90 days
Opioid and/or benzodiazepine withdrawal symptoms.
Measured: 90 days
Adverse effects.
Measured: 90 days
Duration of hospital stay.
Measured: 90 days
Ventilator-free days (number of days alive and breathing unaided within the first 28 days after intubation).
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startJan 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiration, ArtificialStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Sponsor
- Investigators
- Mark C Duffett, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959062
- Sponsor's protocol ID
- NIF09213
- Acronym
- NAPS Pilot
- Status last verified
- Aug 2014
- First submitted
- 13 Aug 2009
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Duffett M, Choong K, Foster J, Cheng J, Meade MO, Menon K, Cook DJ. Clonidine in the sedation of mechanically ventilated children: a pilot randomized trial. J Crit Care. 2014 Oct;29(5):758-63. doi: 10.1016/j.jcrc.2014.05.029. Epub 2014 Jun 11.
PubMed 25015006
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Approaches to Pediatric Sedation: Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children (NAPS Pilot Trial)
- ClinicalTrials.gov ID
- NCT00959062
- Acronym / sponsor ID
- NAPS Pilot / NIF09213
- Keywords
- Pilot Study, Randomized Controlled Trial, Critically Ill, Child, Pediatric, Clonidine, Sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- Jan 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 14 Aug 2009 (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.
Almost all critically ill children who are mechanically ventilated require sedation and analgesia. Providing effective sedation for children in the PICU requires careful balancing of the need for sedation with the adverse effects associated with sedative medications. Clonidine is often used as an adjunctive sedative and analgesic in children but a well designed and adequately powered randomized trial is required to test the effect of clonidine-based sedation. Because there are no large randomized trials of sedation related interventions among critically ill children there are many unknown factors. This pilot trial, focussing on feasibility outcomes will assess the feasibility of, and inform the design of, a larger randomized controlled trial which will focus on clinically important outcomes.
Detailed description
Almost all critically ill children who are mechanically ventilated require sedation and analgesia. Providing effective sedation for children in the PICU requires careful balancing of the need for sedation with the adverse effects associated with sedative medications. Inadequate sedation may result in undue pain and suffering for children, ventilator dysynchrony and may risk removal of life sustaining devices. Excess sedation limits patients' interaction with their parents and care-givers and may result in delayed weaning from mechanical ventilation, prolonged PICU stay and the attendant risks of increased morbidity. Critically ill children may also experience withdrawal when these medications are stopped. Randomized trails in adults have shown that sedation related interventions can improve patients outcomes, but such trials have not been performed in children.
Clonidine is often used as an adjunctive sedative and analgesic in children but a well designed and adequately powered randomized trial is required to test the effect of clonidine-based sedation. Because there are no large randomized trials of sedation related interventions among critically ill children there are many unknown factors.
This pilot trial, focussing on feasibility outcomes will assess the feasibility of, and inform the design of, a larger randomized controlled trial which will focus on clinically important outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clonidine | Experimental | Drug: clonidine |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- aged 1 month to 18 years
- mechanically ventilated
- the attending physician expects to require mechanical ventilation for at least 2 more days
- requires sedation in the form of: morphine by continuous infusion or greater than 4 intermittent doses in the previous 24 hours or fentanyl as a continuous infusion AND midazolam or lorazepam by continuous infusion or more than 3 intermittent doses of lorazepam or 6 doses of midazolam in the previous 12 hours
- has enteral access (gastric or jejunal feeding tube)
Key exclusion criteria (15 listed)
- hemodynamically unstable
- meet the American College of Critical Care Medicine hemodynamic definition of shock
- hypotensive or tachycardic
- bradycardia, hemodynamically significant cardiac disease or chronic use of anti-hypertensive or diuretic medications
- a traumatic brain injury on admission
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 |
|---|---|---|
| clonidine5 mcg/kg (maximum 200 mcg) enterally every 6 hours | Drug | clonidine |
| placeboPreparation visually identical to clonidine. | Drug | placebo |
Primary outcome
Feasibility of screening procedures.
Time frame: 90 days
Protocol adherence.
Time frame: 90 days
Enrollment rate.
Time frame: 90 days
Timeliness of drug administration.
Time frame: 90 days
5 secondary outcomes
Sedation and analgesia requirements.
Time frame: 90 days
Opioid and/or benzodiazepine withdrawal symptoms.
Time frame: 90 days
Adverse effects.
Time frame: 90 days
Duration of hospital stay.
Time frame: 90 days
Ventilator-free days (number of days alive and breathing unaided within the first 28 days after intubation).
Time frame: 28 days
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 13 Aug 2014.
- Results publication: PubMed 25015006Duffett M, Choong K, Foster J, Cheng J, Meade MO, Menon K, Cook DJ. Clonidine in the sedation of mechanically ventilated children: a pilot randomized trial. J Crit Care. 2014 Oct;29(5):758-63. doi: 10.1016/j.jcrc.2014.05.029. Epub 2014 Jun 11.
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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.
Mark C Duffett principal investigator
Hamilton Health Sciences Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing clonidine in people with Respiration, Artificial and Critical Illness, run by Hamilton Health Sciences Corporation at 2 sites 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 5 inclusion and 15 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 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Feasibility of screening procedures. (time frame: 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00959062, which also lists 1 linked publication.
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 13 Aug 2014.