Clinical trial NCT02727491: Does Pre and Postoperative Dextromethorphan Reduce Post-tonsillectomy Pain in Children?
Official title: A Prospective Randomized Double-blind Placebo Controlled Trial; Does Pre and Postoperative Dextromethorphan Reduce Post-tonsillectomy Pain in Children?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: opioid analgesics,
opioid consumption
adverse effects
postoperative pain
tonsillectomy
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 85
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: integrated assessment of pain scores and opioid use
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: opioid-related adverse effects
timeFrame: up to 24 hours postoperatively
measure: pain scores
timeFrame: 1,2,3,8,9 and 10 hours postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Queen's University
name: Rachel Rooney, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Kawamata T, Omote K, Kawamata M, Namiki A. Premedication with oral dextromethorphan reduces postoperative pain after tonsillectomy. Anesth Analg. 1998 Mar;86(3):594-7. doi: 10.1097/00000539-199803000-00031.
citation: Dawson GS, Seidman P, Ramadan HH. Improved postoperative pain control in pediatric adenotonsillectomy with dextromethorphan. Laryngoscope. 2001 Jul;111(7):1223-6. doi: 10.1097/00005537-200107000-00015.
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citation: Rose JB, Cuy R, Cohen DE, Schreiner MS. Preoperative oral dextromethorphan does not reduce pain or analgesic consumption in children after adenotonsillectomy. Anesth Analg. 1999 Apr;88(4):749-53. doi: 10.1097/00000539-199904000-00012.
citation: Weinbroum AA, Rudick V, Paret G, Ben-Abraham R. The role of dextromethorphan in pain control. Can J Anaesth. 2000 Jun;47(6):585-96. doi: 10.1007/BF03018952.
citation: Brown KA, Laferriere A, Lakheeram I, Moss IR. Recurrent hypoxemia in children is associated with increased analgesic sensitivity to opiates. Anesthesiology. 2006 Oct;105(4):665-9. doi: 10.1097/00000542-200610000-00009.
citation: Steinberg GK, Bell TE, Yenari MA. Dose escalation safety and tolerance study of the N-methyl-D-aspartate antagonist dextromethorphan in neurosurgery patients. J Neurosurg. 1996 May;84(5):860-6. doi: 10.3171/jns.1996.84.5.0860.