Pain
Conditions
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.
Interventions
DRUGMagnesium
DRUGNormal saline
Sponsors
Ann & Robert H Lurie Children's Hospital of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain at Home | 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. |
| Emergence Delirium | 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. |
| Number of Patients With Postoperative Vomiting | 90 minutes | The incidence of postoperative vomiting will be measured while in the recovery room. |
| Postoperative Pain Medication | 90 minutes | Amount of rescue postoperative pain medication needed in the recovery room will be tabulated. |
| Time to PACU Discharge | Approximately 90 minutes | The time to fulfilling discharge criteria, in minutes, from the PACU will be recorded |
| Parent Satisfaction | 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. |
| Respiratory Depression | 90 minutes | The incidence of the presence of respiratory depression will be measured while the patient is in the recovery room. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Magnesium | 30 |
| 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.
Normal saline | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Magnesium | Placebo Infusion | Total |
|---|---|---|---|
| Age, Continuous | 76.5 Months | 76.5 Months | 76.5 Months |
| Body Mass Index | 16.1 kg/m2 | 16.9 kg/m2 | 16.4 kg/m2 |
| Obstructive Sleep Apnea (Yes/No) No | 23 Participants | 22 Participants | 45 Participants |
| Obstructive Sleep Apnea (Yes/No) Yes | 7 Participants | 8 Participants | 15 Participants |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Male | 15 Participants | 15 Participants | 30 Participants |
| Surgical Duration | 36.5 Minutes | 35 Minutes | 35 Minutes |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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.
Time frame: 90 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Magnesium | Postoperative Pain | 30 scores on a scale*minutes |
| Placebo Infusion | Postoperative Pain | 45 scores on a scale*minutes |
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.
Time frame: 5 minutes after awakening in the recovery room
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Magnesium | Emergence Delirium | 5 Units on a scale, PAED |
| Placebo Infusion | Emergence Delirium | 6.5 Units on a scale, PAED |
Secondary
Number of Patients With Postoperative Vomiting
The incidence of postoperative vomiting will be measured while in the recovery room.
Time frame: 90 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Magnesium | Number of Patients With Postoperative Vomiting | 0 participants |
| Placebo Infusion | Number of Patients With Postoperative Vomiting | 0 participants |
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.
Time frame: 7 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Magnesium | Parent Satisfaction | 10 Units on a Numeric Rating Scale |
| Placebo Infusion | Parent Satisfaction | 10 Units on a Numeric Rating Scale |
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.
Time frame: 7 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Magnesium | Postoperative Pain at Home | 5.5 PPPM Scale Score (Range: 0-15) |
| Placebo Infusion | Postoperative Pain at Home | 5 PPPM Scale Score (Range: 0-15) |
Secondary
Postoperative Pain Medication
Amount of rescue postoperative pain medication needed in the recovery room will be tabulated.
Time frame: 90 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Magnesium | Postoperative Pain Medication | 2.0 mg IV morphine |
| Placebo Infusion | Postoperative Pain Medication | 2.5 mg IV morphine |
Secondary
Respiratory Depression
The incidence of the presence of respiratory depression will be measured while the patient is in the recovery room.
Time frame: 90 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Magnesium | Respiratory Depression | 0 Participants |
| Placebo Infusion | Respiratory Depression | 0 Participants |
Secondary
Time to PACU Discharge
The time to fulfilling discharge criteria, in minutes, from the PACU will be recorded
Time frame: Approximately 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Magnesium | Time to PACU Discharge | 57 Minutes | Standard Deviation 19 |
| Placebo Infusion | Time to PACU Discharge | 62 Minutes | Standard Deviation 16 |