Child ComfortPhase 3DOLOREAPEDIANCT01235637
Alfentanil Versus Sufentanil for Pain in Children During for Tracheal Suction
A Phase 3 study testing Alfentanil and Sufentanil in people with Child Comfort and Morphine, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The main objective is to assess the efficacy of Alfentanil for pain in children treated by tracheal suction in pediatric intensive care units in France, compared to Sufentanyl, the current standard treatment. Read more about this study
- Who is it for?
- Ages 1 month to 15 years
- Conditions the study is for
- Child Comfort, Morphine, Intensive Care Units
- What is being tested?
- Alfentanil and Sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Jun 2012
- Phase
- Phase 3
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child between 1 month and 15 years of age
- affiliation to the French social security system or equivalent
- child receiving mechanical ventilation for at least 4 hours and less than 48 hours
- ventilation to be provided for at least 8 hours
- less than 30 days in pediatric intensive care
- child under intravenous sedation
- consent of both parents
- consent of child when possible
Who cannot join
- curarized child
- ketamine treatment
- children suffering from facial and/or severe brain traumatism
- known hypersensitivity reaction to morphine or intolerance insufficiency to sufentanyl
- respiratory
- chronic obstructive pulmonary disease
Show all 11Show fewer
- myasthenia
- treatment with morphine agonists-antagonists, or combination with MAOIs
- renal or liver disorders
- preterm birth of more than one month of life (but not at full term by corrected age)
- associated treatment or pathology contra-indicating administration of Sufentanyl epidural
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Alfentanyl Versus Sufentanyl in Children for Pain During Treatment by Tracheal Suction in an Intensive Care Unit.
The main objective is to assess the efficacy of Alfentanil for pain in children treated by tracheal suction in pediatric intensive care units in France, compared to Sufentanyl, the current standard treatment.
- Conditions
- Child Comfort, Morphine, Intensive Care Units, Pediatric
- Being tested
- Alfentanil, Sufentanil
- Keywords
- COMFORT B score, Bis score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfentanilDrug
dosage form: injectable drug, opioid analgesic morphine, intravenous drug.
Dosage: 10μg/Kg, dilution: 1 ml = volume equivalent to 66μg or 10μg/kg = 1.43μg/kg fentanyl.
Frequency and duration: 2 bolus injection before 2 tracheal suctions at 0 and 4 hours respectively.
SufentanilDrug
dosage form: injectable drug, opioid analgesic morphine, intravenous drug.
Dosage: intravenous drug to 0,15 µg/Kg : Blisters of 10 ml, box of 20. MERCK
Frequency and duration: 2 bolus injection before 2 tracheal suctions at 0 and 4 hours respectively.
| Study group | Role | What they receive |
|---|---|---|
| Alfentanil | Active comparator | Not described Receives: Drug: Alfentanil |
| Sufentanil | Sham comparator | Not described Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
COMFORT score
pain score recommended in pediatric intensive care units in France
Measured: 8 hours
Secondary outcomes (2)
Hemodynamic criteria
blood pressure and heart rate
Measured: 8 hours
Bispectral Index score
assess the level of child's sedation
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Child ComfortStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle WROBLEWSKI, MD PHD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235637
- Sponsor's protocol ID
- DCIC 10 10
- Acronym
- DOLOREAPEDIA
- Status last verified
- Jul 2012
- First submitted
- 4 Nov 2010
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stanik-Hutt JA, Soeken KL, Belcher AE, Fontaine DK, Gift AG. Pain experiences of traumatically injured patients in a critical care setting. Am J Crit Care. 2001 Jul;10(4):252-9.
PubMed 11432213Ista E, van Dijk M, Tibboel D, de Hoog M. Assessment of sedation levels in pediatric intensive care patients can be improved by using the COMFORT "behavior" scale. Pediatr Crit Care Med. 2005 Jan;6(1):58-63. doi: 10.1097/01.PCC.0000149318.40279.1A.
PubMed 15636661Triltsch AE, Nestmann G, Orawa H, Moshirzadeh M, Sander M, Grosse J, Genahr A, Konertz W, Spies CD. Bispectral index versus COMFORT score to determine the level of sedation in paediatric intensive care unit patients: a prospective study. Crit Care. 2005 Feb;9(1):R9-17. doi: 10.1186/cc2977. Epub 2004 Nov 10.
PubMed 15693968Brocas E, Dupont H, Paugam-Burtz C, Servin F, Mantz J, Desmonts JM. Bispectral index variations during tracheal suction in mechanically ventilated critically ill patients: effect of an alfentanil bolus. Intensive Care Med. 2002 Feb;28(2):211-3. doi: 10.1007/s00134-001-1189-y. Epub 2002 Jan 12.
PubMed 11907667Veyckemans F. [Sedation in children: how and for who?]. Arch Pediatr. 2006 Jun;13(6):835-7. doi: 10.1016/j.arcped.2006.03.131. Epub 2006 May 12. No abstract available. French.
PubMed 16697580
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Alfentanyl Versus Sufentanyl in Children for Pain During Treatment by Tracheal Suction in an Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT01235637
- Acronym / sponsor ID
- DOLOREAPEDIA / DCIC 10 10
- Conditions
- Child Comfort, Morphine, Intensive Care Units, Pediatric
- Keywords
- COMFORT B score, Bis score
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 5 Nov 2010 (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 main objective is to assess the efficacy of Alfentanil for pain in children treated by tracheal suction in pediatric intensive care units in France, compared to Sufentanyl, the current standard treatment.
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 |
|---|---|---|
| Alfentanil | Active comparator | Drug: Alfentanil |
| Sufentanil | Sham comparator | Drug: Sufentanil |
Who may qualify
- Ages
- 1 month to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- child between 1 month and 15 years of age
- affiliation to the French social security system or equivalent
- child receiving mechanical ventilation for at least 4 hours and less than 48 hours
- ventilation to be provided for at least 8 hours
- less than 30 days in pediatric intensive care
Key exclusion criteria (11 listed)
- curarized child
- ketamine treatment
- children suffering from facial and/or severe brain traumatism
- known hypersensitivity reaction to morphine or intolerance insufficiency to sufentanyl
- respiratory
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 |
|---|---|---|
| Alfentanildosage form: injectable drug, opioid analgesic morphine, intravenous drug. Dosage: 10μg/Kg, dilution: 1 ml = volume equivalent to 66μg or 10μg/kg = 1.43μg/kg fentanyl. Frequency and duration: 2 bolus injection before 2 tracheal suctions at 0 and 4 hours respectively. | Drug | Alfentanil |
| Sufentanildosage form: injectable drug, opioid analgesic morphine, intravenous drug. Dosage: intravenous drug to 0,15 µg/Kg : Blisters of 10 ml, box of 20. MERCK Frequency and duration: 2 bolus injection before 2 tracheal suctions at 0 and 4 hours respectively. | Drug | Sufentanil |
Primary outcome
COMFORT score
Time frame: 8 hours
pain score recommended in pediatric intensive care units in France
2 secondary outcomes
Hemodynamic criteria
Time frame: 8 hours
Bispectral Index score
Time frame: 8 hours
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 4 Jul 2012.
- Background: PubMed 11432213Stanik-Hutt JA, Soeken KL, Belcher AE, Fontaine DK, Gift AG. Pain experiences of traumatically injured patients in a critical care setting. Am J Crit Care. 2001 Jul;10(4):252-9.
- Background: PubMed 15636661Ista E, van Dijk M, Tibboel D, de Hoog M. Assessment of sedation levels in pediatric intensive care patients can be improved by using the COMFORT "behavior" scale. Pediatr Crit Care Med. 2005 Jan;6(1):58-63. doi: 10.1097/01.PCC.0000149318.40279.1A.
- Background: PubMed 15693968Triltsch AE, Nestmann G, Orawa H, Moshirzadeh M, Sander M, Grosse J, Genahr A, Konertz W, Spies CD. Bispectral index versus COMFORT score to determine the level of sedation in paediatric intensive care unit patients: a prospective study. Crit Care. 2005 Feb;9(1):R9-17. doi: 10.1186/cc2977. Epub 2004 Nov 10.
- Background: PubMed 11907667Brocas E, Dupont H, Paugam-Burtz C, Servin F, Mantz J, Desmonts JM. Bispectral index variations during tracheal suction in mechanically ventilated critically ill patients: effect of an alfentanil bolus. Intensive Care Med. 2002 Feb;28(2):211-3. doi: 10.1007/s00134-001-1189-y. Epub 2002 Jan 12.
- Background: PubMed 16697580Veyckemans F. [Sedation in children: how and for who?]. Arch Pediatr. 2006 Jun;13(6):835-7. doi: 10.1016/j.arcped.2006.03.131. Epub 2006 May 12. No abstract available. French.
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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.
Isabelle WROBLEWSKI, MD PHD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alfentanil and Sufentanil in people with Child Comfort and Morphine, run by University Hospital, Grenoble at 1 site in France.
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 8 inclusion and 11 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 4 Jul 2012. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
COMFORT score (time frame: 8 hours). 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 NCT01235637, which also lists 5 linked publications.
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 4 Jul 2012.