Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02651324
Other study ID # 3497
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received January 6, 2016
Last updated June 29, 2017
Start date May 2013
Est. completion date December 2017

Study information

Verified date June 2017
Source Albany Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study hypothesizes that the addition of a low-dose ketamine infusion to usual post-operative pain management will improve pain control as evidenced by an improvement in post-operative pain scores for patients undergoing spinal fusion for idiopathic scoliosis.


Description:

After consenting, patients will be randomized by the pharmacy. In the operating room patients will receive ketamine/placebo 0.5mg/kg bolus prior to the surgical incision, followed by ketamine/placebo 0.2mg/kg continuous infusion up to 48hours. All the patients will also receive 15mg/k IV acetaminophen at the end of the surgery, followed by every 6hr for 48hrs. Rest of the pain regimen will be the usual post-operative pain management for spinal fusion for idiopathic scoliosis, which includes morphine PCA, IV ketorolac from POD 1, and flexaril from POD 1.

All the patients and parents will fill out a survey at 0hr, 24hr and 48hr grading their level of satisfaction with the post-operative pain.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- ASA I, II, III

- Presenting for spinal fusion for idiopathic scoliosis

- English-speaking and able to give assent

Exclusion Criteria:

- Any contraindication to ketamine

- Previous spinal surgery

- Opioid dependence

- Chronic pain condition

- Significant developmental delay

- Pregnancy

Study Design


Intervention

Drug:
Ketamine

Other:
Placebo


Locations

Country Name City State
United States Albany Medical Center Albany New York

Sponsors (1)

Lead Sponsor Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

References & Publications (11)

Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. — View Citation

Carstensen M, Møller AM. Adding ketamine to morphine for intravenous patient-controlled analgesia for acute postoperative pain: a qualitative review of randomized trials. Br J Anaesth. 2010 Apr;104(4):401-6. doi: 10.1093/bja/aeq041. Epub 2010 Mar 5. Review. — View Citation

Cha MH, Eom JH, Lee YS, Kim WY, Park YC, Min SH, Kim JH. Beneficial effects of adding ketamine to intravenous patient-controlled analgesia with fentanyl after the Nuss procedure in pediatric patients. Yonsei Med J. 2012 Mar;53(2):427-32. doi: 10.3349/ymj.2012.53.2.427. — View Citation

DA Conceição MJ, Bruggemann DA Conceição D, Carneiro Leão C. Effect of an intravenous single dose of ketamine on postoperative pain in tonsillectomy patients. Paediatr Anaesth. 2006 Sep;16(9):962-7. — View Citation

Green SM, Clark R, Hostetler MA, Cohen M, Carlson D, Rothrock SG. Inadvertent ketamine overdose in children: clinical manifestations and outcome. Ann Emerg Med. 1999 Oct;34(4 Pt 1):492-7. — View Citation

Mathews TJ, Churchhouse AM, Housden T, Dunning J. Does adding ketamine to morphine patient-controlled analgesia safely improve post-thoracotomy pain? Interact Cardiovasc Thorac Surg. 2012 Feb;14(2):194-9. doi: 10.1093/icvts/ivr081. Epub 2011 Nov 28. Review. — View Citation

Michelet P, Guervilly C, Hélaine A, Avaro JP, Blayac D, Gaillat F, Dantin T, Thomas P, Kerbaul F. Adding ketamine to morphine for patient-controlled analgesia after thoracic surgery: influence on morphine consumption, respiratory function, and nocturnal desaturation. Br J Anaesth. 2007 Sep;99(3):396-403. Epub 2007 Jun 18. — View Citation

Subramaniam K, Subramaniam B, Steinbrook RA. Ketamine as adjuvant analgesic to opioids: a quantitative and qualitative systematic review. Anesth Analg. 2004 Aug;99(2):482-95, table of contents. Review. — View Citation

Tsui BC, Wagner A, Mahood J, Moreau M. Adjunct continuous intravenous ketamine infusion for postoperative pain relief following posterior spinal instrumentation for correction of scoliosis: a case report. Paediatr Anaesth. 2007 Apr;17(4):383-6. — View Citation

Yamauchi M, Asano M, Watanabe M, Iwasaki S, Furuse S, Namiki A. Continuous low-dose ketamine improves the analgesic effects of fentanyl patient-controlled analgesia after cervical spine surgery. Anesth Analg. 2008 Sep;107(3):1041-4. doi: 10.1213/ane.0b013e31817f1e4a. — View Citation

Zakine J, Samarcq D, Lorne E, Moubarak M, Montravers P, Beloucif S, Dupont H. Postoperative ketamine administration decreases morphine consumption in major abdominal surgery: a prospective, randomized, double-blind, controlled study. Anesth Analg. 2008 Jun;106(6):1856-61. doi: 10.1213/ane.0b013e3181732776. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Satisfaction All the patients and parent will fill out a survey grading their level of satisfaction with their post-operative pain management Through study completion, 48 hours
Secondary Pain Score Pain scores will be collected from the nursing sheet Through study completion 48 hours
Secondary Opioid Use Total Morphine consumption will be collected from PCA data Through study completion, 48 hours
Secondary Length of Stay Length of hospital stay from surgery to discharge Through study completion, 48 hours
See also
  Status Clinical Trial Phase
Completed NCT02489526 - Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injections for Post-Operative Pain Following Colorectal Surgery Phase 2
Terminated NCT05146453 - Sternotomies and PectoIntercostal Fascia Blocks in Fast-Track Cardiac Anesthesiology Phase 4
Completed NCT05635916 - Trial of Liposomal Bupivacaine for TKA Phase 4
Recruiting NCT06028126 - Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial N/A
Not yet recruiting NCT03591172 - Using Three Different Final Irrigants and Showing Their Effects on the Success of Revascularization N/A
Completed NCT01667445 - Evaluation of the Use of Spinal Epimorph in Total Knee Arthroplasty Phase 4
Completed NCT01686802 - Post-operative Oral Morphine Versus Ibuprofen Phase 2
Completed NCT01444924 - Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery Phase 2
Completed NCT00830089 - Trial of a Transversus Abdominis Plane (TAP) Block in Laparoscopic Colorectal Surgery N/A
Completed NCT00968955 - Effect of Local Infiltration Analgesia in Total Hip Arthroplasty Phase 4
Terminated NCT00875862 - Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks Phase 4
Completed NCT00847093 - LMX-4 for Postoperative Pain Management in Infants and Children Undergoing Penoplasty Surgery Phase 4
Completed NCT00390312 - Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction Phase 2
Recruiting NCT05278494 - Dextromethorphan for Treatment of Postoperative Pain N/A
Recruiting NCT05973045 - Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk, and Post-operative Pain in Operative Hysteroscopy N/A
Not yet recruiting NCT04999670 - Fascial Closure and Post-caesarean Pain N/A
Enrolling by invitation NCT04346407 - Dronabinol for Post-operative Pain After Lumbar Fusion Phase 4
Completed NCT03635515 - Occurrence of Post-op Pain Following Gentlewave N/A
Terminated NCT03201809 - Comparison of Preoperative Ultrasound Guided Pectoralis Nerve Block Placement Versus Intra-operative Placement: A Prospective Randomized Trial N/A
Completed NCT03254056 - Fascial Closure Techniques Post-Operative Pain Laparoscopy N/A