A Dose Ranging Effect of Preoperative Diphenhydramine on Postoperative Quality of Recovery After Ambulatory Surgery

NCT01451762 | Completed Results

• 1 other identifier: STU00044695
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Surgery; Pain

Keywords

pain; anesthesia; surgery; postoperative

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

.9 normal saline IV

Drug: .9 normal saline

25 mg diphenhydramine IV

ACTIVE COMPARATOR

25 mg diphenhydramine IV administered before surgery

Drug: 25 mg diphenhydramine IV

50 mg diphenhydramine IV

ACTIVE COMPARATOR

50 mg diphenhydramine IV administered before surgery

Drug: 50 mg diphenhydramine IV

Interventions

.9 normal saline DRUG

.9 normal saline administered before surgery.

Placebo

25 mg diphenhydramine IV DRUG

25 mg diphenhydramine IV administered before surgery

25 mg diphenhydramine IV

50 mg diphenhydramine IV DRUG

50 mg diphenhydramine administered IV before surgery

50 mg diphenhydramine IV

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (2)

Prentice Womens HOspital

Chicago, Illinois, 60611, United States

Location

Prentice Womens HOsptial

Chicago, Illinois, 60611, United States

Location

Related Publications (8)

• 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.

  PMID: 12873949 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.

  PMID: 17703887 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.

  PMID: 8105724 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.

  PMID: 20010418 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.

  PMID: 9315918 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.

  PMID: 6188566 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.

  PMID: 2578597 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.

  PMID: 11350529 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

• Title: Gildasio De Oliveira MD
• Organization: Northwestern University

g-jr@northwestern.edu

312-472-3573

Study Officials

• Gildasio De Oliveira, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gildasio De Oliveira, M.D. Principal Investigator

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: October 14, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 14, 2014
• Results First Posted: March 14, 2014

Record last verified: 2014-02

Locations

US (2)