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Quality Improvement Analysis 3rd Quarter 2002 One-Step Topical Anesthetic / Dilating Drop Study 1) Identification of an important problem/concern. The process for preparing each patient for cataract eye surgery is laborintensive and time-consuming. Pre-op dilating eye drops ordered by the surgeon must be started after the patient has been registered on admission, their consent form has been explained and they have signed it, and their admission assessment has been completed. There is often inadequate time for the dilating drops to be fully effective before the patient needs to be taken into the O.R. Secondly, patients often complain about the discomfort of receiving the eye drops. 2) Evaluation of the frequency, severity, and source of the problem / concern. The patients scheduled for cataract surgery must be admitted at least an hour before their anticipated surgery time in order to receive the multiples of eye drops multiple times to ensure adequate dilation of their pupil. The patients are often anxious and unhappy about the long wait-time between their arrival and the actual start time of their surgery. The pupil-dilation process is started by the RN as soon as possible after the patient is admitted. However, when the surgical procedure is short in duration and the time between cases is very short, there is often too short a time interval from the time the final set of dilating drops have been given until the time the patient is to be taken into the O.R. for surgery. Therefore, the pupil of the operative eye is often inadequately dilated for the procedure. In addition, the instillation of the drops often causes a burning discomfort for the patient even when preceded by a drop of Alcaine (proparacaine.) The repeated process of drop instillation adds to the pre-operative anxiety and discomfort for many of the patients. 3) Measures Implemented to Resolve the Problem / Concern A study of a time-saving and cost-saving method was proposed for administering a pre-mixed combination of dilating, antibiotic, and antiinflammatory eye drops combined with anesthetic jelly and instilling this mixture into the operative eye of forty (40) cataract surgery patients. This method was based on the study that was done at the Gossage Eye Institute in Hillsdale, MI and published in Ophthalmology Times (June 15, 2002.) For assistance with your QI Program, contact: [email protected] Page 1 of 5 The mixture can easily be made by the RN’s pre-operatively the morning of surgery according to the following formula: 4mL 2% Lidocaine jelly 4gtts 1% Tropicamide Ophth. Sol. (Mydriacyl) 4gtts 2% Cyclopentolate HCl Ophth. Sol. (Cyclogyl) 4gtts 10% Phenylephrine HCl Ophth. Sol. (Ak-Dilate) 4gtts 0.5% Ketorolac tromethamine Ophth. Sol. (Acular) 4gtts 0.3% Ofloxacin Ophth. Sol. (Ocuflox) This mixture totals approximately 4mL and provides about 16 doses. Using strict aseptic technique, the ingredients are thoroughly mixed in a sterile cup with a sterile needle cap. Approximately 0.25mL is drawn through a largebore blunt needle into a TB syringe for each dose and the syringe is recapped in an aseptic manner. Pre-made labels with the ingredients, the date, and the initials of the RN are affixed to each syringe. One TB syringe equals one dose (of approximately 0.25mL.) which equals one liberal strip placed into the inferior cul-de-sac of the operative eye. It takes approximately 20 minutes for it to take effect. The operative eye is taped shut following each application to allow the mixture to penetrate the ocular tissues and prevent the eye from drying out. Additional applications can be added every 20 minutes. The mixture initially may be administered by the RN with a written order from the surgeon. Subsequent doses are administered per the anesthesiologist on an “as needed” basis. Pre-printed Physician Orders sheets are provided for each patient, signed by the physician, and noted by the RN. For the purpose of doing the study, information was entered onto a preprinted monitoring sheet that was placed in each patient’s pre-op file. (See accompanying form.) As a means for comparison, a “control” group of twentyfive (25) patients who received the traditional method of drop administration and anesthetic (either topical or eye block) were also evaluated. Rather than focusing on the obvious time-saving, cost-saving, and safety value of the onestep topical method, our focus during the study was on the effectiveness of the mixture to adequately dilate the pupil for surgery and on the patient’s comfort level during their procedure. Therefore the following information was obtained and evaluated: Amount of pupil dilation 20 minutes after initial application of mixture. The need for additional application(s) of mixture for additional pupil dilation and/or additional anesthetic level. The need for additional drops or mechanical means for pupil dilation. The need for additional anesthetic medication(s) and/or adjuncts for pain control. Each patient’s rating of comfort vs. discomfort with the use of “0 to 10 Rating Scale” (with “0” as no discomfort and “10” as the worst pain they can imagine.) For assistance with your QI Program, contact: [email protected] Page 2 of 5 Study Results: C = Control Group of 25 patients. (All 25 patients received the traditional 4-drop regimen every 5 minutes x3.) S = Study Group of 40 Patients. Pupil dilation 20 minutes after initial application of mixture: <4mm 4-4.5mm 5-5.5mm 6-6.5mm 7-7.5mm 8mm 9mm C: None None 2(15%) 2(15% ) 1(7%) 2(15%) 4(30%) S: None 5(15%) 3(9%) 9(28%) 6(18%) 7(22%) 2(6%) 10mm Not indicated None 12 1(3%) 8 At least one additional dose of mixture was needed as determined by anesthesiologist: C: N/A S: No =20 Yes = 20 (Note: during the first part of the study the anesthesiologist gave a second dose of mixture for additional anesthetic effect. However, he later found that two doses of plain Lidocaine jelly after the initial dose of mixture gave a better anesthetic effect.) Additional dilating eye drops were needed: C: No = 23 Yes = 2 S: No = 28 Yes = 12 (4 pts needed addit. dil. gtts after 2nd dose of mixture.) Additional dilation with a surgical instrument was needed. C: No = 25 Yes = 0 S: No = 40 Yes = 0 Additional anesthetic medication(s) and/or adjuncts were needed during surgery: C: No = 25 Yes = 0 S: No = 39 Yes = 1 (first pt in study group rec’d addit Lido Jelly plus narcotic & Versed in the O.R.) Note: the first pt in the study group to receive the mixture received only the one dose before surgery & no additional topical anesthetic in pre-op.) Patient pain scale rating for surgical discomfort (based on 0 – 10): 0-1 (no pain) 2 3 4 >4 C: 25 S: 38 None One One None 4. Re-evaluation Based on Study Data The study showed that the Lidocaine/drop mixture was well tolerated by the patients with no complaints of discomfort with application. At least 70% of the study patients had an adequate pupil dilation result 20 minutes after the initial dose. The anesthetic result after one dose was not adequate, however. All patients receiving topical anesthesia (with or without dilating drops added) need 2-3 doses of the Lidocaine jelly to be comfortable during their surgery. The study also showed that the admission process could be shortened by at least 5 minutes per patient with the one application method. 5. All results of the study reported to the Total Quality Management Committee and the Governing Body. For assistance with your QI Program, contact: [email protected] Page 3 of 5 PHYSICIAN’S ORDERS Date of Surgery __________________ Patient’s Name _____________________________ Consent For: CATARACT EXTRACTION WITH IOL RIGHT EYE Date Time Orders Dilate RIGHT eye with 0.25cc of the following mixture. 2% Lidocaine Jelly – 4mL 1% Mydriacyl – 4gtts 2% Cyclogyl – 4gtts 10% Ak-Dilate – 4gtts 0.5% Acular – 4gtts 0.3% Ocuflox – 4gtts Repeat x1 in 20 minutes per request of anesthesiologist. IV or Saline Lock per anesthesiologist. Additional pre-op anesthesia and Honan cuff per anesthesiologist. LUMIGAN – one (1) drop, CILOXAN - one (1) drop, and ECONO-PRED – one (1) drop in RIGHT eye post-op in the O.R. DIAMOX 250mg - one (1) tablet by mouth @ time of discharge. Discharge when stable with pack provided by office. John Smith, M.D. Another brand of a generically equivalent product as approved by the Pharmacy & Therapeutics Committee may be administered unless the physician states otherwise. John Smith, M.D. 1234 Sunshine Drive Happy Valley, CA 12345 (800) 123-4567 9/02 QA Study For assistance with your QI Program, contact: [email protected] Page 4 of 5 One-Step Topical Anesthetic / Dilating Drop Combination QA Study Patient Evaluation Form Date:_____________ Pre-op: Patient’s allergies verified. Lidocaine / dilating drop mixture administered: No – reason:__________________________________________ Yes – OS / OD Time:______________ Medicated eye taped shut RN signature:_____________________________ Pupil dilation 20 minutes after administration:_____mm. Noted by:____________ Additional dose(s) mixture administered: Time:_____ Administered by:___________________________________ Time:_____ Administered by:___________________________________ Pupil dilation:___mm @ (time):_____noted by:___________________________ ___mm @ (time):_____noted by:___________________________ Additional lidocaine jelly (without added drops) administered by anesthesiologist: No Yes:_______________________________________________ Additional administration of dilating eye drops needed: No Yes – type:__________________________________________ Intra-op: Pt experienced discomfort in operative eye during prep and/or surgery: No Yes:________________________________________________ Additional anesthetic was needed: No Yes If yes, type: Tetracaine / Alcaine gtts Lidocaine injection by surgeon IV sedation by anesthesiologist Other:______________________________ Additional dilation was needed with surgical instrument: No Yes:________________________________________________ Post-op: Patient’s rating of discomfort to eye during surgery: 0 1 2 3 4 5 6 7 8 9 10 Least pain ----------------------------------------------------------- Worst pain Other adverse reaction noted: No Yes:_______________________ Comments: -----------------------------------------------------Patient Label – Do not write in this space For assistance with your QI Program, contact: [email protected] Page 5 of 5