Magnesium vs Placebo for Tonsillectomy
13. december 2018 opdateret af: Hubert Benzon, Ann & Robert H Lurie Children's Hospital of Chicago
Systemic Magnesium to Improve Postoperative Pain in Pediatric Patients Undergoing Tonsillectomy: A Randomized, Double Blinded, Placebo Controlled Trial
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
4 år til 10 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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Placebo komparator: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative Pain
Tidsramme: 90 minutes
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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.
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90 minutes
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative Pain Medication
Tidsramme: 90 minutes
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Amount of rescue postoperative pain medication needed in the recovery room will be tabulated.
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90 minutes
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Postoperative Pain at Home
Tidsramme: 7 days
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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.
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7 days
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Emergence Delirium
Tidsramme: 5 minutes after awakening in the recovery room
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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.
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5 minutes after awakening in the recovery room
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Number of Patients With Postoperative Vomiting
Tidsramme: 90 minutes
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The incidence of postoperative vomiting will be measured while in the recovery room.
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90 minutes
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Respiratory Depression
Tidsramme: 90 minutes
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The incidence of the presence of respiratory depression will be measured while the patient is in the recovery room.
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90 minutes
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Time to PACU Discharge
Tidsramme: Approximately 90 minutes
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The time to fulfilling discharge criteria, in minutes, from the PACU will be recorded
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Approximately 90 minutes
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Parent Satisfaction
Tidsramme: 7 days
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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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7 days
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Hubert A Benzon, MD, MPH, Ann & Robert H Lurie Children's hospital of Chicago
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2014
Primær færdiggørelse (Faktiske)
1. april 2015
Studieafslutning (Faktiske)
1. april 2015
Datoer for studieregistrering
Først indsendt
12. august 2014
Først indsendt, der opfyldte QC-kriterier
14. august 2014
Først opslået (Skøn)
18. august 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. januar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. december 2018
Sidst verificeret
1. december 2018
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2014MagRCT
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .