Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery
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ClinicalTrials.gov Identifier: NCT01531439 |
Recruitment Status
:
Completed
First Posted
: February 13, 2012
Last Update Posted
: July 19, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain, Postoperative Postoperative Nausea and Vomiting Scoliosis | Drug: Naloxone | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 84 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Supportive Care |
Official Title: | Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery |
Actual Study Start Date : | November 2011 |
Actual Primary Completion Date : | May 1, 2015 |
Actual Study Completion Date : | December 1, 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Naloxone infusion 0.5 mcg/kg/hr |
Drug: Naloxone
Naloxone infusion 0.5 mcg/kg/hr
Other Name: Narcan
|
Experimental: Naloxone 2.5 mcg/kg/hr
Naloxone infusion 2.5 mcg/kg/hr
|
Drug: Naloxone
Naloxone infusion 2.5 mcg/kg/hr
Other Name: Narcan
|
- 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.
- Severity of itching [ Time Frame: Assessed daily while in hospital requiring PCA, average 5 days ]Scale presented to subject to complete daily
- Severity of nausea [ Time Frame: Assessed daily while in hospital requiring PCA, average 5 days ]Scale presented to subject daily to rate nausea
- Severity of pain [ Time Frame: Assessed by bedside nurse 3 times daily while requiring PCA ]Scale number 0-10

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Ages Eligible for Study: | 10 Years to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Idiopathic scoliosis requiring spine fusion surgery
- Age 10-21 years
Exclusion Criteria:
- Inability to understand PCA instructions
- Allergy to: morphine, hydromorphone, fentanyl, naloxone, or diphenhydramine
- Chronic opioid therapy > 2 months
- Non-English speaking

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531439
United States, Missouri | |
Children's Mercy Hospital | |
Kansas City, Missouri, United States, 64108 |
Principal Investigator: | Benjamin J. Pieters, DO | Children's Mercy Hospital |
Responsible Party: | Ben J Pieters, Staff Anesthesiologist, Children's Mercy Hospital Kansas City |
ClinicalTrials.gov Identifier: | NCT01531439 History of Changes |
Other Study ID Numbers: |
11 04-059 |
First Posted: | February 13, 2012 Key Record Dates |
Last Update Posted: | July 19, 2017 |
Last Verified: | July 2017 |
Keywords provided by Ben J Pieters, Children's Mercy Hospital Kansas City:
Narcotic Antagonists Naloxone infusion Postoperative pruritis |
Patient controlled analgesia Pediatric Children |
Additional relevant MeSH terms:
Vomiting Scoliosis Pain, Postoperative Postoperative Nausea and Vomiting Signs and Symptoms, Digestive Signs and Symptoms Spinal Curvatures Spinal Diseases Bone Diseases Musculoskeletal Diseases Pain |
Neurologic Manifestations Nervous System Diseases Postoperative Complications Pathologic Processes Nausea Naloxone Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |