Does Pre and Postoperative Dextromethorphan Reduce Post-tonsillectomy Pain in Children?
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Dextromethorphan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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).; 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 intervention name(s): dextromethorphan hydrobromide; control
Intervention MeSH terms: Dextromethorphan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: opioid analgesics,; opioid consumption; adverse effects; postoperative pain; tonsillectomy