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Magnesium vs Placebo for Tonsillectomy

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ClinicalTrials.gov Identifier: NCT02218424
Recruitment Status : Completed
First Posted : August 18, 2014
Results First Posted : December 14, 2018
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Hubert Benzon, Ann & Robert H Lurie Children's Hospital of Chicago

Brief Summary:

This study is a double-blind randomized controlled trial using intravenous magnesium versus placebo to determine if systemic magnesium can decrease postoperative pain in pediatric patients undergoing tonsillectomy.

Participants will be in one of two arms. Those in Arm 1 will receive magnesium (30 mg/kg bolus followed by a 10mg/kg/hr infusion) while those in Arm 2 will receive an equal volume of normal saline bolus followed by infusion (placebo).

The primary objective is to determine if systemic magnesium will decrease postoperative pain in patients undergoing tonsillectomy. The secondary objectives will determine if systemic magnesium administration is associated with a decrease in opioid-related side effects, decrease the incidence of emergence delirium, and improve postoperative functional recovery.

The study hypothesis is that the use of intravenous magnesium will decrease postoperative pain, decrease opioid-related side effects, decrease the incidence of emergence delirium, and improve functional recovery in patients undergoing tonsillectomy.


Condition or disease Intervention/treatment Phase
Pain Drug: Magnesium Drug: Normal saline Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Systemic Magnesium to Improve Postoperative Pain in Pediatric Patients Undergoing Tonsillectomy: A Randomized, Double Blinded, Placebo Controlled Trial
Study Start Date : October 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis
Drug Information available for: Magnesium

Arm Intervention/treatment
Experimental: Magnesium
Intravenous magnesium. After IV placed intraoperatively, a bolus dose of magnesium 30 mg/kg is given over 15 minutes, followed by a continuous infusion of magnesium at 10 mg/kg/hr until the completion of the procedure.
Drug: Magnesium
Placebo Comparator: Placebo infusion
Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group.
Drug: Normal saline



Primary Outcome Measures :
  1. Postoperative Pain [ Time Frame: 90 minutes ]
    Postoperative pain will be measured at 15 minute time intervals in the post-anesthesia care unit (PACU). Pain scores will be evaluated using a standardized validated scale (the Faces Pain Scale Revised (FPS-R)). The Faces Pain Scale is a validated, patient reported, 0 (no pain) to 10 (worst pain imaginable) numeric rating scale. Pain scores will be multiplied by the time spent at each pain score for a calculated "Area Under the Curve" value, ranging from 0 to 900, with lower values indicating more favorable and lower pain scores.


Secondary Outcome Measures :
  1. Postoperative Pain Medication [ Time Frame: 90 minutes ]
    Amount of rescue postoperative pain medication needed in the recovery room will be tabulated.

  2. Postoperative Pain at Home [ Time Frame: 7 days ]
    Postoperative pain at home will be measured using the Parent's Post-Operative Pain Measure (PPPM) questionnaire on postoperative days 1, 3, and 7. The PPPM gives a score to child behavior which suggests they are in pain after surgery with scores ranging from 0 to 15 with lower values suggesting better pain outcome.

  3. Emergence Delirium [ Time Frame: 5 minutes after awakening in the recovery room ]
    The incidence of emergence delirium determined using the pediatric anesthesia emergence delirium (PAED) scale while the patient is in the PACU. The PAED scale ranges from scores of 0 to 20, with lower scores indicating less agitation, more awareness, less aggressiveness, and a more favorable outcome in the post-anesthesia recovery period.

  4. Number of Patients With Postoperative Vomiting [ Time Frame: 90 minutes ]
    The incidence of postoperative vomiting will be measured while in the recovery room.

  5. Respiratory Depression [ Time Frame: 90 minutes ]
    The incidence of the presence of respiratory depression will be measured while the patient is in the recovery room.

  6. Time to PACU Discharge [ Time Frame: Approximately 90 minutes ]
    The time to fulfilling discharge criteria, in minutes, from the PACU will be recorded

  7. Parent Satisfaction [ Time Frame: 7 days ]
    Parent satisfaction will be assessed on postoperative days 1, 3, and 7. This will be determined by asking the parents one question about their satisfaction with the overal anesthetic care on a numeric rating scale of 1 to 10, with higher scores indicating greater satisfaction and better outcome.



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Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients aged 4-10 years old undergoing tonsillectomy by a single surgeon and under the care of that participating surgeon
  • American Society of Anesthesiology (ASA) patient classification of I-III

Exclusion Criteria:

  • Physical or developmental delay
  • Psychiatric illness
  • Current use of sedative or anticonvulsant medication
  • Pre-existing renal disease
  • Pre-existing cardiovascular disease
  • Regular use of analgesic medication
  • Having other procedures in addition to tonsillectomy (however, patients undergoing adenoidectomy with their tonsillectomy will be included in the study)

Information from the National Library of Medicine

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): NCT02218424


Locations
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United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
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Principal Investigator: Hubert A Benzon, MD, MPH Ann & Robert H Lurie Children's Hospital of Chicago
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Responsible Party: Hubert Benzon, Principal Investigator, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT02218424    
Other Study ID Numbers: 2014MagRCT
First Posted: August 18, 2014    Key Record Dates
Results First Posted: December 14, 2018
Last Update Posted: January 3, 2019
Last Verified: December 2018