Skip to main content
OpenTrials
Completed

NCT Number: NCT02218424

Magnesium vs Placebo for Tonsillectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Magnesium

Drug

normal saline

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

Systemic Magnesium to Improve Postoperative Pain in Pediatric Patients Undergoing Tonsillectomy: A Randomized, Double Blinded, Placebo Controlled Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 18, 2014
Registry last updated
Jan 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.