A Dose Ranging Effect of Preoperative Diphenhydramine on Postoperative Quality of Recovery After Ambulatory Surgery
NCT ID: NCT01451762
Last Updated: 2014-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2011-09-30
2012-09-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo
.9 normal saline IV
.9 normal saline
.9 normal saline administered before surgery.
25 mg diphenhydramine IV
25 mg diphenhydramine IV administered before surgery
25 mg diphenhydramine IV
25 mg diphenhydramine IV administered before surgery
50 mg diphenhydramine IV
50 mg diphenhydramine IV administered before surgery
50 mg diphenhydramine IV
50 mg diphenhydramine administered IV before surgery
Interventions
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.9 normal saline
.9 normal saline administered before surgery.
25 mg diphenhydramine IV
25 mg diphenhydramine IV administered before surgery
50 mg diphenhydramine IV
50 mg diphenhydramine administered IV before surgery
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing ambulatory surgery
* ASA PS I, II.
Exclusion Criteria
* pregnant patient or lactating patients
* allergy to diphenhydramine
* glaucoma
* uncontrolled hypertension
* asthma
* hyperthyroidism
* cardiovascular disease
18 Years
64 Years
FEMALE
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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Gildasio De Oliveira
Gildasio De Oliveira, M.D. Principal Investigator
Principal Investigators
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Gildasio De Oliveira, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Prentice Womens HOspital
Chicago, Illinois, United States
Prentice Womens HOsptial
Chicago, Illinois, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Raffa RB. Antihistamines as analgesics. J Clin Pharm Ther. 2001 Apr;26(2):81-5. doi: 10.1046/j.1365-2710.2001.00330.x.
Other Identifiers
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STU00044695
Identifier Type: -
Identifier Source: org_study_id
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