Magnesium vs Placebo for Tonsillectomy

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02218424
• Other study ID #: 2014MagRCT
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 2014
• Est. completion date: April 2015

Study information

• Verified date: December 2018
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Magnesium

• Normal saline

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain	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.	90 minutes
Secondary	Postoperative Pain Medication	Amount of rescue postoperative pain medication needed in the recovery room will be tabulated.	90 minutes
Secondary	Postoperative Pain at Home	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.	7 days
Secondary	Emergence Delirium	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.	5 minutes after awakening in the recovery room
Secondary	Number of Patients With Postoperative Vomiting	The incidence of postoperative vomiting will be measured while in the recovery room.	90 minutes
Secondary	Respiratory Depression	The incidence of the presence of respiratory depression will be measured while the patient is in the recovery room.	90 minutes
Secondary	Time to PACU Discharge	The time to fulfilling discharge criteria, in minutes, from the PACU will be recorded	Approximately 90 minutes
Secondary	Parent Satisfaction	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.	7 days