Pain, Surgery
Conditions
Keywords
pain, anesthesia, surgery, postoperative
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.
Interventions
DRUG.9 normal saline
.9 normal saline administered before surgery.
DRUG25 mg diphenhydramine IV
25 mg diphenhydramine IV administered before surgery
DRUG50 mg diphenhydramine IV
50 mg diphenhydramine administered IV before surgery
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery 40 at 24 Hours | 24 hours post operatively | Scores on QOR (quality of recovery) 40 questionnaire.The QoR-40 score, which ranges from 40 to 200, representing very poor to outstanding quality of recovery, respectively. |
Countries
United States
Participant flow
Recruitment details
90 subjects were enrolled between September 2011 and September 2012.
Participants by arm
| Arm | Count |
|---|---|
| Placebo .9 normal saline IV | 30 |
| 25 mg Diphenhydramine IV 25 mg diphenhydramine IV administered before surgery | 30 |
| 50 mg Diphenhydramine IV 50 mg diphenhydramine IV administered before surgery | 30 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 6 | 6 |
Baseline characteristics
| Characteristic | 25 mg Diphenhydramine IV | 50 mg Diphenhydramine IV | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 30 Participants | 90 Participants |
| Age, Continuous | 36.5 years STANDARD_DEVIATION 10.7 | 37 years STANDARD_DEVIATION 8.3 | 35 years STANDARD_DEVIATION 8.36 | 37 years STANDARD_DEVIATION 9.1 |
| Region of Enrollment United States | 30 participants | 30 participants | 30 participants | 90 participants |
| Sex: Female, Male Female | 30 Participants | 30 Participants | 30 Participants | 90 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 27 | 9 / 24 | 3 / 24 |
| serious Total, serious adverse events | 0 / 27 | 0 / 24 | 0 / 24 |
Outcome results
Primary
Quality of Recovery 40 at 24 Hours
Scores on QOR (quality of recovery) 40 questionnaire.The QoR-40 score, which ranges from 40 to 200, representing very poor to outstanding quality of recovery, respectively.
Time frame: 24 hours post operatively
Population: Primary outcome was QOR 40 a sample size of 23 per group was estimated to achieve 80% power to detect a 10 point difference in aggregated QOR040 score for the three groups. A 10 point difference represents a clinically relevant improvement in quality of recovery. TO account for drop outs lost to follow up 90 subjects were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Quality of Recovery 40 at 24 Hours | 164 units on scale 40 (low) - 200 (high) |
| 25 mg Diphenhydramine IV | Quality of Recovery 40 at 24 Hours | 169 units on scale 40 (low) - 200 (high) |
| 50 mg Diphenhydramine IV | Quality of Recovery 40 at 24 Hours | 172 units on scale 40 (low) - 200 (high) |