Clinical trial NCT01451762: A Dose Ranging Effect of Preoperative Diphenhydramine on Postoperative Quality of Recovery After Ambulatory Surgery
Official title: A Dose Ranging Effect of Preoperative Diphenhydramine on Postoperative Quality of Recovery After Ambulatory Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Pain
Keywords: pain
anesthesia
surgery
postoperative
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2011-10-14
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pain after ambulatory surgery remains an unsolved problem in The United States and Europe. It is associated with delayed hospital discharge and it can result to an increased opioid consumption with adverse side effects. The concept of multimodal analgesic technique was introduced more than 15 years ago and several techniques have been studied over the years including non steroidal antiinflammatory drugs (NSAIDs), acetaminophen, gabapentoids, ketamine, local and regional anesthetic techniques. Histamine can have effects on polymodal nociceptors and C-fibers, producing pain which is further increased by neurogenically mediated release of substance P from afferent pain fibers. Several non-selective or H1 -selective histamine receptors antagonists have been demonstrated in animal models and clinical pain. Chia et al demonstrated that preoperative promethazine had opioid sparing properties without adverse sedative effects in patients undergoing abdominal hysterectomy.

Diphenhydramine is an anti-histamine drug who has been found to be effective in reducing postoperative nausea and vomiting after ambulatory surgery but its effects on postoperative pain and other important outcomes after ambulatory surgery such as time to meet discharge criteria have not being studied.

The MQOR 40 is a validated instrument that was specifically design to evaluate patient recovery after anesthesia and surgery. This instrument can be particularly valid to examine interventions which affect different spheres of patient recovery as is the case of diphenhydramine. The objective of this study is to determine a dose response effect of preoperative diphenhydramine on postoperative quality of recovery after ambulatory surgery. The use of preoperative diphenhydramine can improve patient's quality of recovery, decrease postoperative pain, opioid consumption and opioid related side effects after ambulatory surgery.

The research question: Does a preoperative dose of diphenhydramine improve postoperative quality of recovery after ambulatory surgery? The hypothesis of this study is that preoperative diphenhydramine will improve postoperative pain, Postoperative nausea and vomiting (PONV), sleep which will translate in a better overall quality of recovery.


Eligibility criteria: Inclusion Criteria:

* Age 18-64 years
* Patients undergoing ambulatory surgery
* ASA PS I, II.

Exclusion Criteria:

* Chronic opioid use
* pregnant patient or lactating patients
* allergy to diphenhydramine
* glaucoma
* uncontrolled hypertension
* asthma
* hyperthyroidism
* cardiovascular disease

Primary outcomes:
measure: Quality of Recovery 40 at 24 Hours
timeFrame: 24 hours post operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Prentice Womens HOspital
state: Illinois
city: Chicago
country: United States
facility: Prentice Womens HOsptial
state: Illinois
Study officials:
affiliation: Northwestern University
name: Gildasio De Oliveira, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Benhamou D, Berti M, Brodner G, De Andres J, Draisci G, Moreno-Azcoita M, Neugebauer EA, Schwenk W, Torres LM, Viel E. Postoperative Analgesic THerapy Observational Survey (PATHOS): a practice pattern study in 7 central/southern European countries. Pain. 2008 May;136(1-2):134-41. doi: 10.1016/j.pain.2007.06.028. Epub 2007 Aug 20.
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