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

Sponsor

Dr. Rachel Rooney (Other)

Overall Status

Completed

CT.gov ID

NCT02727491

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: Dextromethorphan Drug: Placebo	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

85 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dextromethorphan 1 mg/kg of dextromethorphan syrup orally 30 min preoperatively and then again 8 hours post-tonsillectomy	Drug: Dextromethorphan 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 Comparator: Placebo 30 min preoperatively and then again 8 hours postoperatively, received inactive placebo syrup identical in volume, appearance and taste as the experimental group	Drug: Placebo 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

Arm

Intervention/Treatment

Experimental: dextromethorphan

1 mg/kg of dextromethorphan syrup orally 30 min preoperatively and then again 8 hours post-tonsillectomy

Drug: Dextromethorphan

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 Comparator: Placebo

30 min preoperatively and then again 8 hours postoperatively, received inactive placebo syrup identical in volume, appearance and taste as the experimental group

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

integrated assessment of pain scores and opioid use [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 Outcome Measures

opioid-related adverse effects [up to 24 hours postoperatively]
nausea, vomiting, respiratory depression, bleeding
pain scores [1,2,3,8,9 and 10 hours postoperatively]
Pain scores at rest on the CHEOPS pain scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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