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Completed

NCT Number: NCT02727491

Does Pre and Postoperative Dextromethorphan Reduce Post-tonsillectomy Pain in Children?

With Institutional ethics board and Health Canada approval, pediatric patients (ages 3-12) undergoing tonsillectomy or adenotonsillectomy (under standardized anesthesia) will be randomized to receive dextromethorphan hydrobromide (1mg/kg orally) 30 min preoperatively and again 8 hours postoperatively OR placebo (syrup identical in taste, appearance and volume) at the same time points. The primary outcome is an integrated assessment of perioperative pain scores and opioid use for 24 hours postoperatively. Secondary outcomes include nausea, vomiting, respiratory depression, and bleeding for 24 hours postoperatively. Our hypothesis is that dextromethorphan will decrease the incidence/severity of post-tonsillectomy pain. The improved pain control will be apparent through reduced opioid consumption and integrated pain scores. This will result in a reduced incidence of opioid-related side effects and adverse events.

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Key information

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

With Institutional ethics board and Health Canada approval and parental consent and child assent, pediatric patients (ages 3-12) undergoing tonsillectomy or adenotonsillectomy (under standardized anesthesia) will be randomized to receive dextromethorphan hydrobromide (1mg/kg orally) 30 min preoperatively and again 8 hours postoperatively OR placebo (syrup identical in taste, appearance and volume) at the same time points. The primary outcome is an integrated assessment of perioperative pain scores and opioid use for 24 hours postoperatively. Pain scores were collected preoperatively at rest and then at 1,2,3,8,9,10 and 24 hours postoperatively using the validated Children's Hospital of Eastern Ontario Pain Scale (CHEOPS). Secondary outcomes include nausea, vomiting, respiratory depression, and bleeding recorded by blinded observers for 24 hours postoperatively.

Our hypothesis is that dextromethorphan will decrease the incidence/severity of post-tonsillectomy pain. The improved pain control will be apparent through reduced opioid consumption and integrated pain scores. This will result in a reduced incidence of opioid-related side effects and adverse events.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologist's (ASA) physical classification I and II
  • tonsillectomy or adenotonsillectomy
  • admission to extended postoperative care unit

Exclusion criteria

  • use of monoamine oxidase inhibitors, serotonin reuptake inhibitors or tricyclic antidepressants
  • requirement of preoperative sedation
  • recent dextromethorphan use (<24 h before surgery)
  • intolerance, sensitivity or contraindication to any agents used in the study
  • pre-existing chronic pain or chronic analgesic use
  • body mass index (BMI) for age percentile greater than 90
  • confounding procedural factors which might affect the validity of the data
  • inability to adhere to study protocol
  • contraindication to volatile anesthetics

Treatment and study plan

dextromethorphan

Drug

Dextromethorphan is a drug of the morphinan class with sedative, dissociative, and stimulant properties (at higher doses). Dextromethorphan has been explored for a number other uses in medicine, including pain relief (as either the primary analgesic, or an opioid potentiator).

Other names: dextromethorphan hydrobromide

Placebo

Drug

Placebo syrup identical to active comparator in taste, appearance and volume but is inactive. Placebo comparator will be used in the placebo arm of the trial.

Other names: control

Primary outcomes

  1. integrated assessment of pain scores and opioid use

    Time frame: 24 hours postoperatively

    The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) will be measured at rest 24 hours postoperatively and this will be integrated with total opioid consumption at 24 hours postoperatively. This will be achieved by converting both pain scores and opioid consumption to % change. The % differences for each of the 2 variables are then added together on a per-subject basis to provide a summated % difference. The individual and summated % differences can then be plotted on a single graph and the integrated ranks of the experimental and control groups can be compared with standard statistical tests.(1)

Secondary outcomes

  1. opioid-related adverse effects

    Time frame: up to 24 hours postoperatively

    nausea, vomiting, respiratory depression, bleeding

  2. pain scores

    Time frame: 1,2,3,8,9 and 10 hours postoperatively

    Pain scores at rest on the CHEOPS pain scale

Sponsors and collaborators

Lead sponsor

Dr. Rachel Rooney

Other

Registry information

Official study title

A Prospective Randomized Double-blind Placebo Controlled Trial; Does Pre and Postoperative Dextromethorphan Reduce Post-tonsillectomy Pain in Children?

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 4, 2016
Registry last updated
Sep 21, 2020

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.

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