ScoliosisPhase 3NCT00737997
Effect of Early Morphine Administration on the Development of Acute Opioid Tolerance During Pediatric Scoliosis Surgery
A Phase 3 study testing Morphine and Saline in people with Scoliosis, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The purpose of this study is to examine if morphine administered by bolus before initiating Remifentanil by infusion decreases the incidence of acute post-operative opioid tolerance as demonstrated by decreased post - operative morphine consumption in children undergoing scoliosis surgery. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- Morphine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2006to Feb 2008
- 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Unpremedicated
- ASA physical status 1 or 2
- Aged 11 - 18
- Scheduled to undergo posterior instrumentation for correction of idiopathic scoliosis
Who cannot join
- Chronic opioid use within three months prior to surgery
- Inability to self-administer morphine using a patient-controlled analgesia (PCA) device
- Elective postoperative ventilation
- Obesity (> 130% ideal body weight)
- Known sensitivity to morphine, remifentanil or any other agent within the standardized protocol
- Failure to obtain written consent or assent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Early Administration of Morphine on the Development of Acute Opioid Tolerance During Infusion of Remifentanil for Pediatric Scoliosis Surgery
The purpose of this study is to examine if morphine administered by bolus before initiating Remifentanil by infusion decreases the incidence of acute post-operative opioid tolerance as demonstrated by decreased post - operative morphine consumption in children undergoing scoliosis surgery.
Read the detailed description
At our institution, a study has recently demonstrated that intraoperative infusion of remifentanil is associated with development of clinically relevant acute opioid tolerance in adolescents undergoing scoliosis surgery. This results in increased morphine consumption which in turn is associated with increased incidence of side effects such as respiratory depression, nausea and vomiting, pruritus, ileus and urinary retention. All of these side effects can result in increased consumption of rescue medications with the additional potential for increased duration of patient stay. Any measures that can be introduced to decrease the development of acute opioid tolerance in this patient population would have significant impact on patient morbidity, patient comfort and possibly duration of patient stay.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
150 mcg/kg diluted in normal saline to a volume of 10 ml at time of induction of anesthesia
SalineOther
10 ml saline alone
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Other: Saline |
| 2 | Experimental | Not described Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Measured: Every hour for four hours and then every four hours thereafter for 48 hours
Secondary outcomes (2)
Propofol and remifentanil consumption
Measured: 48 hours
Incidences of post-operative nausea, vomiting, pruritus and pyrexia
Measured: every hour for four hours and then every four hours thereafter for 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startDec 2006
- Primary completionDec 2007
- Study completionFeb 2008
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 ScoliosisStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Crawford, The Hospital for Sick Children
- Investigators
- Mark Crawford, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737997
- Sponsor's protocol ID
- 1000009741
- Status last verified
- Nov 2014
- First submitted
- 18 Aug 2008
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
McDonnell C, Zaarour C, Hull R, Thalayasingam P, Pehora C, Ahier J, Crawford MW. Pre-treatment with morphine does not prevent the development of remifentanil-induced hyperalgesia. Can J Anaesth. 2008 Dec;55(12):813-8. doi: 10.1007/BF03034052.
PubMed 19050084
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Administration of Morphine on the Development of Acute Opioid Tolerance During Infusion of Remifentanil for Pediatric Scoliosis Surgery
- ClinicalTrials.gov ID
- NCT00737997
- Acronym / sponsor ID
- 1000009741
- Conditions
- Scoliosis
- Keywords
- Pediatrics, Scoliosis, Morphine, Surgery, Analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 20 Aug 2008 (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 purpose of this study is to examine if morphine administered by bolus before initiating Remifentanil by infusion decreases the incidence of acute post-operative opioid tolerance as demonstrated by decreased post - operative morphine consumption in children undergoing scoliosis surgery.
Detailed description
At our institution, a study has recently demonstrated that intraoperative infusion of remifentanil is associated with development of clinically relevant acute opioid tolerance in adolescents undergoing scoliosis surgery. This results in increased morphine consumption which in turn is associated with increased incidence of side effects such as respiratory depression, nausea and vomiting, pruritus, ileus and urinary retention. All of these side effects can result in increased consumption of rescue medications with the additional potential for increased duration of patient stay. Any measures that can be introduced to decrease the development of acute opioid tolerance in this patient population would have significant impact on patient morbidity, patient comfort and possibly duration of patient stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: Saline |
| 2 | Experimental | Drug: Morphine |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Unpremedicated
- ASA physical status 1 or 2
- Aged 11 - 18
- Scheduled to undergo posterior instrumentation for correction of idiopathic scoliosis
Key exclusion criteria (6 listed)
- Chronic opioid use within three months prior to surgery
- Inability to self-administer morphine using a patient-controlled analgesia (PCA) device
- Elective postoperative ventilation
- Obesity (> 130% ideal body weight)
- Known sensitivity to morphine, remifentanil or any other agent within the standardized protocol
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 |
|---|---|---|
| Morphine150 mcg/kg diluted in normal saline to a volume of 10 ml at time of induction of anesthesia | Drug | 2 |
| Saline10 ml saline alone | Other | 1 |
Primary outcome
Morphine consumption
Time frame: Every hour for four hours and then every four hours thereafter for 48 hours
2 secondary outcomes
Propofol and remifentanil consumption
Time frame: 48 hours
Incidences of post-operative nausea, vomiting, pruritus and pyrexia
Time frame: every hour for four hours and then every four hours thereafter for 48 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 19 Nov 2014.
- Derived from this study: PubMed 19050084McDonnell C, Zaarour C, Hull R, Thalayasingam P, Pehora C, Ahier J, Crawford MW. Pre-treatment with morphine does not prevent the development of remifentanil-induced hyperalgesia. Can J Anaesth. 2008 Dec;55(12):813-8. doi: 10.1007/BF03034052.
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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 Crawford, MD principal investigator
The Hospital for Sick Children, Toronto Canada
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 Morphine and Saline in people with Scoliosis, run by The Hospital for Sick Children at 1 site 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 4 inclusion and 6 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 19 Nov 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 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 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?
Morphine consumption (time frame: Every hour for four hours and then every four hours thereafter for 48 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 NCT00737997, 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 19 Nov 2014.