NCT02727491

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

Completed Phase 4 Last updated 17 September 2020

What this trial tests

Phase 4 trial testing Dextromethorphan in Pain, Postoperative in 85 participants. Completed in 1 September 2014.

Timeline

1 March 2012

Primary endpoint
1 September 2014

1 September 2014

Quick facts

Lead sponsor	Dr. Rachel Rooney
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	85
Start date	1 March 2012
Primary completion	1 September 2014
Estimated completion	1 September 2014

Drugs / interventions tested

• Dextromethorphan — full drug profile →
• Placebo

Conditions studied

• Pain, Postoperative — all drugs for Pain, Postoperative →

Sponsor

Dr. Rachel Rooney

Who can join

Adults 3 to 12, any sex, with Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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 summa

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.