Pain, PostoperativeNCT01531439
Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery
A study testing Naloxone in people with Pain, Postoperative and Postoperative Nausea and Vomiting, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
There will be two groups in this study: one group will be given the standard infusion of naloxone, a drug which helps reduce side effects from opioids needed after surgery, and the other group will receive a higher dose. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Pain, Postoperative, Postoperative Nausea and Vomiting, Scoliosis
- What is being tested?
- Naloxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to 1 Dec 2016
- Phase
- Interventional
- 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 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Idiopathic scoliosis requiring spine fusion surgery
- Age 10-21 years
Who cannot join
- Inability to understand PCA instructions
- Allergy to: morphine, hydromorphone, fentanyl, naloxone, or diphenhydramine
- Chronic opioid therapy > 2 months
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
There will be two groups in this study: one group will be given the standard infusion of naloxone, a drug which helps reduce side effects from opioids needed after surgery, and the other group will receive a higher dose. The trial is designed to determine if a higher dose of naloxone infusion will reduce side effects from opioid therapy in patients who have undergone spine fusion for scoliosis.
Read the detailed description
Currently, patients undergoing spinal fusion for scoliosis are routinely given patient controlled analgesia (PCA) for pain control postoperatively. PCA therapy is typically combined with an ultra low dose naloxone infusion because of the established benefit of reduced pruritis and nausea. The investigators hypothesize that using a higher dose naloxone infusion may lead to further improvement in pruritis and nausea and may improve GI function. Improvement in bowel function could lead to faster initiation of oral intake as well as transition to oral pain medication and even decreased length of stay.
- Being tested
- Naloxone
- Keywords
- Narcotic Antagonists, Naloxone infusion, Postoperative pruritis, Patient controlled analgesia, Pediatric, Children
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaloxoneDrug
Also called Narcan
Naloxone infusion 0.5 mcg/kg/hr
NaloxoneDrug
Also called Narcan
Naloxone infusion 2.5 mcg/kg/hr
| Study group | Role | What they receive |
|---|---|---|
| Naloxone infusion 0.5 mcg/kg/hr | Active comparator | Not described Receives: Drug: Naloxone |
| Naloxone 2.5 mcg/kg/hr | Experimental | Naloxone infusion 2.5 mcg/kg/hr Receives: Drug: Naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Hours Until Tolerating Oral Intake
Defined as time when awakening after surgery until tolerating orals.
Measured: Assessed daily in hospital while in hospital until taking orals, average 4 days.
Secondary outcomes (3)
Severity of Itching
Visual analog scale presented to subject to complete daily. Minimum value 0 "none" to maximum value 10 "worst possible". Higher scores represent worse outcome.
Title of scale "Itching VAS".
Scores were assessed daily for 5 days and an average of the five days was reported.
Measured: Assessed daily while in hospital requiring PCA
Severity of Nausea
Nausea VAS presented to subject daily. Zero minimum "none" to 10 maximum "worse possible". Higher scores represent worse clinical outcome.
Name of scale "Nausea VAS".
Scores were assessed daily for 5 days and an average of the five days reported.
Measured: Assessed daily while in hospital requiring PCA.
Severity of Pain
Visual analog scale for pain. Zero "none" minimum to 10 "worse possible" maximum.
Name of scale "Pain VAS".
Scores were assessed daily for 5 days and an average of the five days was reported.
Measured: Assessed by bedside nurse 3 times daily while requiring PCA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startNov 2011
- Primary completion1 May 2015
- Study completion1 Dec 2016
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 Pain, PostoperativeStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben J Pieters, Children's Mercy Hospital Kansas City
- Investigators
- Benjamin J. Pieters, DO, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531439
- Sponsor's protocol ID
- 11 04-059
- Status last verified
- Sep 2020
- First submitted
- 20 Jun 2011
- Last updated
- 10 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery
- ClinicalTrials.gov ID
- NCT01531439
- Acronym / sponsor ID
- 11 04-059
- Keywords
- Narcotic Antagonists, Naloxone infusion, Postoperative pruritis, Patient controlled analgesia, Pediatric, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Nov 2011 (actual)
- Primary completion
- 1 May 2015 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 13 Feb 2012 (estimated)
- Results
- Posted 10 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There will be two groups in this study: one group will be given the standard infusion of naloxone, a drug which helps reduce side effects from opioids needed after surgery, and the other group will receive a higher dose. The trial is designed to determine if a higher dose of naloxone infusion will reduce side effects from opioid therapy in patients who have undergone spine fusion for scoliosis.
Detailed description
Currently, patients undergoing spinal fusion for scoliosis are routinely given patient controlled analgesia (PCA) for pain control postoperatively. PCA therapy is typically combined with an ultra low dose naloxone infusion because of the established benefit of reduced pruritis and nausea. The investigators hypothesize that using a higher dose naloxone infusion may lead to further improvement in pruritis and nausea and may improve GI function. Improvement in bowel function could lead to faster initiation of oral intake as well as transition to oral pain medication and even decreased length of stay.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naloxone infusion 0.5 mcg/kg/hr | Active comparator | Drug: Naloxone |
| Naloxone 2.5 mcg/kg/hr | Experimental | Drug: NaloxoneNaloxone infusion 2.5 mcg/kg/hr |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Idiopathic scoliosis requiring spine fusion surgery
- Age 10-21 years
Key exclusion criteria (4 listed)
- Inability to understand PCA instructions
- Allergy to: morphine, hydromorphone, fentanyl, naloxone, or diphenhydramine
- Chronic opioid therapy > 2 months
- Non-English speaking
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 |
|---|---|---|
| NaloxoneAlso: NarcanNaloxone infusion 0.5 mcg/kg/hr | Drug | Naloxone infusion 0.5 mcg/kg/hr |
| NaloxoneAlso: NarcanNaloxone infusion 2.5 mcg/kg/hr | Drug | Naloxone 2.5 mcg/kg/hr |
Primary outcome
Number of Hours Until Tolerating Oral Intake
Time frame: Assessed daily in hospital while in hospital until taking orals, average 4 days.
Defined as time when awakening after surgery until tolerating orals.
3 secondary outcomes
Severity of Itching
Time frame: Assessed daily while in hospital requiring PCA
Severity of Nausea
Time frame: Assessed daily while in hospital requiring PCA.
Severity of Pain
Time frame: Assessed by bedside nurse 3 times daily while requiring PCA
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Benjamin J. Pieters, DO principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naloxone in people with Pain, Postoperative and Postoperative Nausea and Vomiting, run by Children's Mercy Hospital Kansas City 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 2 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 10 Sep 2020. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2020). 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?
Number of Hours Until Tolerating Oral Intake (time frame: Assessed daily in hospital while in hospital until taking orals, average 4 days.). 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 10 Sep 2020.