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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | .9 normal saline IV |
|
| 25 mg diphenhydramine IV | Active Comparator | 25 mg diphenhydramine IV administered before surgery |
|
| 50 mg diphenhydramine IV | Active Comparator | 50 mg diphenhydramine IV administered before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| .9 normal saline | Drug | .9 normal saline administered before surgery. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours post operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gildasio De Oliveira, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prentice Womens HOspital | Chicago | Illinois | 60611 | United States | ||
| Prentice Womens HOsptial |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12873949 | Background | Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E. | |
| 17703887 | Background | 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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90 subjects were enrolled between September 2011 and September 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | .9 normal saline IV |
| FG001 | 25 mg Diphenhydramine IV | 25 mg diphenhydramine IV administered before surgery |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 25 mg diphenhydramine IV |
| Drug |
25 mg diphenhydramine IV administered before surgery |
|
| 50 mg diphenhydramine IV | Drug | 50 mg diphenhydramine administered IV before surgery |
|
| Chicago |
| Illinois |
| 60611 |
| United States |
| 8105724 | Background | Kehlet H, Dahl JB. The value of "multimodal" or "balanced analgesia" in postoperative pain treatment. Anesth Analg. 1993 Nov;77(5):1048-56. doi: 10.1213/00000539-199311000-00030. No abstract available. |
| 20010418 | Background | White PF, Kehlet H. Improving postoperative pain management: what are the unresolved issues? Anesthesiology. 2010 Jan;112(1):220-5. doi: 10.1097/ALN.0b013e3181c6316e. No abstract available. |
| 9315918 | Background | Schmelz M, Schmidt R, Bickel A, Handwerker HO, Torebjork HE. Specific C-receptors for itch in human skin. J Neurosci. 1997 Oct 15;17(20):8003-8. doi: 10.1523/JNEUROSCI.17-20-08003.1997. |
| 6188566 | Background | Baird-Lambert J, Jamieson DD. Possible mediators of the writhing response induced by acetic acid or phenylbenzoquinone in mice. Clin Exp Pharmacol Physiol. 1983 Jan-Feb;10(1):15-20. doi: 10.1111/j.1440-1681.1983.tb00166.x. |
| 2578597 | Background | Rumore MM, Schlichting DA. Analgesic effects of antihistaminics. Life Sci. 1985 Feb 4;36(5):403-16. doi: 10.1016/0024-3205(85)90252-8. |
| 11350529 | Background | Raffa RB. Antihistamines as analgesics. J Clin Pharm Ther. 2001 Apr;26(2):81-5. doi: 10.1046/j.1365-2710.2001.00330.x. |
| FG002 | 50 mg Diphenhydramine IV | 50 mg diphenhydramine IV administered before surgery |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | .9 normal saline IV |
| BG001 | 25 mg Diphenhydramine IV | 25 mg diphenhydramine IV administered before surgery |
| BG002 | 50 mg Diphenhydramine IV | 50 mg diphenhydramine IV administered before surgery |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Median | Inter-Quartile Range | units on scale 40 (low) - 200 (high) | 24 hours post operatively |
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24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | .9 normal saline IV | 0 | 27 | 12 | 27 | ||
| EG001 | 25 mg Diphenhydramine IV | 25 mg diphenhydramine IV administered before surgery | 0 | 24 | 9 | 24 | ||
| EG002 | 50 mg Diphenhydramine IV | 50 mg diphenhydramine IV administered before surgery | 0 | 24 | 3 | 24 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
We did not obtain preoperative quality of recovery scores of patients therefore we could not examine whether the effect of diphenhydramine was dependent upon patient's baseline characteristics.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gildasio De Oliveira MD | Northwestern University | 312-472-3573 | g-jr@northwestern.edu |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Between 18 and 65 years |
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| >=65 years |
|
| Male |
|