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
Results First Posted : September 10, 2020
Last Update Posted : September 10, 2020
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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
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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 ]
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.
- Severity of Nausea [ Time Frame: Assessed daily while in hospital requiring PCA. ]
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.
- Severity of Pain [ Time Frame: Assessed by bedside nurse 3 times daily while requiring PCA ]
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.

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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 Kansas City |
Responsible Party: | Ben J Pieters, Staff Anesthesiologist, Children's Mercy Hospital Kansas City |
ClinicalTrials.gov Identifier: | NCT01531439 |
Other Study ID Numbers: |
11 04-059 |
First Posted: | February 13, 2012 Key Record Dates |
Results First Posted: | September 10, 2020 |
Last Update Posted: | September 10, 2020 |
Last Verified: | September 2020 |
Narcotic Antagonists Naloxone infusion Postoperative pruritis |
Patient controlled analgesia Pediatric Children |
Scoliosis Vomiting Pain, Postoperative Postoperative Nausea and Vomiting Nausea Signs and Symptoms, Digestive Postoperative Complications Pathologic Processes Pain Neurologic Manifestations |
Spinal Curvatures Spinal Diseases Bone Diseases Musculoskeletal Diseases Naloxone Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |