Colonoscopy without premedication versus barium enema: a comparison of patient discomfort

0016-5107/96/4402-017755.00 + 0 GASTROINTESTINAL ENDOSCOPY Copyright © 1996 by the American Society for Gastrointestinal Endoscopy

Colonoscopy without premedication versus barium enema: a comparison of patient discomfort Volker F. Eckardt, MD, Gerd Kanzler, MD, Dieter Willems, MD Alexander J. Eckardt, Gudrun Bernhard, PhD Mainz, Germany

Background: Colonoscopy is considered a painful procedure requiring routine intravenous sedation. We investigated whether unsedated colonoscopy causes more discomfort than barium enema. Methods: Procedure-related discomfort was determined in 100 consecutive patients undergoing colonoscopy without premedication and in an equal number of patients referred for sigmoidoscopy and barium enema. All patients underwent such examinations for the first time and had no history of previous bowel surgery. During colonoscopy, sedation was offered if significant pain or discomfort occurred. Results: In patients without stenosis and with satisfactory preparation, the completion rate of colonoscopy was 95%. Five percent of all patients undergoing endoscopy required sedation. On an analog scale ranging from 1 to 9, patients undergoing colonoscopy and barium enema reported similar ratings for procedure related discomfort (3.2 _+ 1.7 and 3.1 ± 1.9) and for discomfort caused by bowel preparation (3.2 - 2.1 and 3.1 ± 1.8). Eighty-seven percent of all patients undergoing colonoscopy stated that they would prefer no premedication in the event of repeated examinations. Conclusions: Colonoscopy with sedation on demand does not cause more discomfort than barium enema and will be accepted by the vast majority of patients undergoing this procedure. (Gastrointest Endosc 1996;44:177-80.)

Colonoscopy is considered a highly invasive procedure causing significant discomfort and anxiety to most patients undergoing such examinations. To minimize pain, nearly all endoscopists use intravenous anesthesia with opiates and sedatives at the beginning of the procedure. However, the use of these drugs m a y be associated with severe hypoxemia and carReceived April 27, 1995. For revision June 9, 1995. Accepted November 27, 1995. From the Gastroenterologisches Institut Wiesbaden and Institut fi~r Medizinische Statistik und Dokumentation, Universit~t Mainz, Mainz, Germany. Presented in part at the annual meeting of the American Society for Gastrointestinal Endoscopy, May 1995, San Diego, California (Gastrointest Endosc 1995;41:335). Reprint requests: Volker F. Eckardt, MD, Dotzheimer Str. 14-18, 65185 Wiesbaden, Germany. 37/1/71046

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diopulmonary depression 1-5 requiring interventions in up to one third of all patients undergoing colonoscopy. 6 It has been estimated that between 50% and 60% of all morbidity and mortality occurring during endoscopic procedures is directly related to the administration of sedatives and narcotics. 7 It has been occasionally argued that the use of premedications for lower gastrointestinal endoscopies not only causes significant morbidity but perhaps is not justified in view of the degree of discomfort that colonoscopy may cause, s, 9 It has even been suggested that most patients would rather accept a certain degree of discomfort than the risks involved in routine premedication} ° To our knowledge, no information exists as to whether unsedated colonoscopy exposes the patient to more pain and discomfort than any other procedure for investigation of the gastrointestinal tract. To further elaborate this question, we GASTROINTESTINAL ENDOSCOPY 177

Table 1. Characteristics of patients undergoing colonoscopy and barium enema Variable

Colonoscopy Barium enema

Age (y) 52.3 ± 15.5 Male/female ratio 43/57 Prior pelvic surgery (%) 29 Regular laxative use (%) 12 Diverticulosis (%) 14 Indication for study Bleeding (%) 29 Pain (%) 34 Irregular bowel movements (%) 17 Others (%) 20

57.6 ± 15.5 39/61 22 17 19 38 35 11 16

u n d e r t o o k a prospective s t u d y to d e t e r m i n e p a t i e n t tolerance for u n s e d a t e d colonoscopy v e r s u s b a r i u m enema.

MATERIALS AND METHODS Between July and November 1994, 100 consecutive patients referred for colonoscopy and an identical number of patients referred for sigmoidoscopy with double-contrast barium enema were investigated. Patients were admitted to the studyifthey had undergone neither previous large bowel investigations nor colon surgery. Prior to the examination, all patients were given structured interviews with regard to a history of cardiopulmonary diseases, previous pelvic surgery, frequency of bowel movements, and possible laxative abuse. In addition, the main indication for performing the colon investigation was recorded. Preparation for barium enema included a 24-hour fasting period, the administration of laxatives on the evening preceding the examination, and Fleet enemas on the same morning of the examination.ll Patients undergoing colonoscopy fasted from 6 PM the previous evening and ingested 2 L of a PEG/electrolyte solution (Klean-prep, Norgine) on the evening before as well as on the morning of the examination. All patients were informed in detail concerning the method and goals of this triM. Radiographic and endoscopic examinations were performed in an Internal Medicine consultation office by two senior gastroenterologists (V.F.E. and G.K.) and one physician with special interest in gastrointestinal radiology (D.W.). All of them had more than 20 years of experience in performing these procedures, During the examinations, the endoscopist was joined by two nurses while the radiologist was assisted by an x-ray technician. Double-contrast barium enema was performed using a modified Malta5 technique 12 with routine intravenous administration of 20 to 40 mg butylscopolamine bromide. A Pentax FC 38FH colonoscope (Pentax, Hamburg, Germany) was used for the endoscopic examinations, which were always performed in an x-ray suite, providing the option of using fluoroscopic control. All colonoscopies were commenced without premedication. However, intravenous sedation with midazolam was offered if significant pain or discomfort occurred. During the procedure, one of the two assisting nurses continuously observed the patient and recorded vital signs. Blood pressure and pulse were regularly recorded prior to insertion of the 178 G A S T R O I N T E S T I N A L E N D O S C O P Y

endoscope, following passage of the sigmoid loop, and immediately after termination of the procedure. In addition, the length of time required to reach the cecum was noted. In patients undergoing barium enema, vital signs were obtained at the beginning and end of the procedure. Ratings of discomfort were obtained immediately after the radiographic and colonoscopic investigations. In patients undergoing colonoscopy, the rating applied to the endoscopic procedure, whereas patients undergoing barium enema plus sigmoidoscopy rated the discomfort created by the sum of both procedures. For this purpose, patients were asked to indicate the degree of compromise on an analog scale ranging from 1 to 9. Similar ratings were requested for their tolerance of bowel preparation. Patients undergoing colonoscopy were also asked whether or not they would prefer premedication in the event of repeated examinations. Finally, all patients were asked to fill out an identical questionnaire on the following day and to return it by marl in a prestamped and self-addressed envelope. Eighty-five percent of patients undergoing colonoscopy and 82% of those examined with barium enema complied with the latter request. Statistical analysis was performed according to the study protocol. The distribution of the investigated parameters is described as mean -+ 1 SD. Differences in gradings of discomfort between colonoscopy and barium enema were evaluated using the two-sample t test. Ap value of less than 0.05 was regarded as significant.

RESULTS Characteristics of patients and procedures As s h o w n in T a b l e 1, p a t i e n t s u n d e r g o i n g colonoscopy w e r e slightly y o u n g e r t h a n those r e f e r r e d for b a r i u m e n e m a (p = 0.002) b u t h a d a s i m i l a r sex distribution. I n addition, use of laxatives, p r e s e n c e or absence of diverticulosis, f r e q u e n c y of pelvic surgery, a n d indications for colonic i n v e s t i g a t i o n s w e r e s i m i l a r in t h e two groups. C o m p l e t e colonoscopy w a s p e r f o r m e d in 90% of all patients. I n five cases, complete i n s e r t i o n of t h e i n s t r u m e n t w a s p r e v e n t e d e i t h e r b y poor bowel prepa r a t i o n (1) or highly stenosing lesions such as diverticulitis (1), e n d o m e t r i o s i s (1), a n d colon cancer (2). Thus, the a d j u s t e d completion r a t e w a s 95%. I n p a t i e n t s w i t h successful endoscopic e x a m i n a t i o n s , the m e a n t i m e r e q u i r e d to r e a c h t h e c e c u m w a s 9.2 _+ 5.3 minutes.

Discomfort during colonoscopy and barium enema The g r e a t m a j o r i t y of p a t i e n t s considered the discomfort c a u s e d b y b o t h e x a m i n a t i o n s to be mild. On the a n a l o g scale, colonoscopy received a s i m i l a r m e a n discomfort score ( 3 . 2 _+ 1.7) as b a r i u m e n e m a (3.1 +_ 1.9). As s h o w n in Figure 1, no significant c h a n g e in t h e s e r a t i n g s occurred w h e n t h e s a m e q u e s t i o n n a i r e w a s a n s w e r e d on t h e d a y following t h e p r o c e d u r e (colonoscopy, 3.4 _+ 1.9; b a r i u m e n e m a , 3.3 _+ 1.9). D u r i n g colonoscopy, five p a t i e n t s received VOLUME 44, NO. 2, 1996

!

A BP (mmHg}

Sigmoid Passage

End of Examination Colonoscopy

DAY

1

Barium Enema

30 20 10

best

,L 1

,,

, 3

I

I 5

I

I

I

7

I worst

0

9

I

-10

DAY

I .w -T- '

J

Systole

-20

2

]

-30 A

Figure 1. Mean ratings (_+1 SD) for discomfort caused by colonoscopy (closed boxes) and barium enema (open boxes). Most patients graded both procedures as only mildly uncomfortable and similar ratings were given on repeated questioning.

Diastole

Pulse/min 30 20 10 0

intravenous sedation with midazolam. Two additional patients stated after the procedure that they would have preferred premedication, and six patients changed their mind in favor of premedication on the next day. Thus, 87% of all patients reported a definite preference for no sedation in the event of repeated colonoscopy. In the statistical analysis, sex, regular laxative abuse, previous pelvic surgery, or the presence of diverticulosis did not show a significant impact on the degree of discomfort experienced during either barium enema or colonoscopy. Discomfort caused by bowel preparation

Bowel preparation for colonoscopy and barium enema caused a similar degree of discomfort to that of the diagnostic procedures. The mean discomfort score was 3.2 -_ 2.1 for colonoscopy preparation and 3.1 _+ 1.9 for barium enema preparation. Almost identical ratings were given on the day after the examinations (colonoscopy, 3.3 -+ 1.8; barium enema, 3.1 _+ 1.9). Procedure-related complications and changes in vital signs

Minor complications occurred in two patients during colonoscopy. These consisted of one brief vasovagal reaction and one bleeding episode from a polypectomy site. The former required no treatment, the latter was successfully treated with local epinephrine injection. Two patients undergoing barium enema had vasovagal reactions requiring discontinuation of the radiographic procedure, but both had an immediate and uneventful recovery. As shown in Figure 2, mean blood pressure increased slightly after the colonoscope was passed through the sigmoid colon and decreased significantly (p = 0.001) at termination of the proceVOLUME 44, NO. 2, 1996

-10 -20

Figure 2. Changes in blood pressure and pulse after colonoscopic passage of the sigmoid and at termination of the two procedures. The mild fall in blood pressure and pulse after colonoscopy most likely reflects a decrease in apprehensiveBess.

dure. Similarly, the initially elevated pulse rate (84.1 _+ 14.8 per minute) fell continuously during colonoscopy and reached more normal values (79.1 _+ 13.1 per minute) at its termination (p = 0.001). Opposite changes in pulse frequency were observed after barium enema (p = 0.001), a phenomenon that is most likely related to the administration of a spasmolytic agent (20 to 40 mg butylscopolamine bromide) during the radiographic study. DISCUSSION Most physicians share their patients' prejudice that colonoscopy is always a painful and distressing procedure. As a consequence, almost all patients undergoing this procedure are premedicated with various sedatives and narcotics, 13 which all enhance the risk of cardiopulmonary complications. However, the need for such routine premedication has never been proven by controlled investigations, and almost no information exists as to whether colonoscopy causes any more discomfort than other investigative procedures for which the use ofpremedication is not even considered. For example, no one has ever suggested that barium enemas be performed under intravenous sedation, although this examination is also viewed as unpleasant and uncomfortable. Two previous investigations have addressed the isGASTROINTESTINAL ENDOSCOPY

179

sue of w h e t h e r colonoscopy or b a r i u m e n e m a causes more p a t i e n t discomfort. 14, 15 In the first study, patients expressed a preference for colonoscopy, 14 while the opposite was t r u e in the second. 15 However, in light of the fact t h a t all patients u n d e r g o i n g colonoscopy in these studies were given sedatives as well as narcotics, the reliability of these j u d g e m e n t s has to be questioned. In the c u r r e n t investigation, 95% of patients undergoing colonoscopy received no intravenous sedation a n d the questions were asked immediately after the e x a m i n a t i o n as well as on the day after. On both occasions, ratings of discomfort were usually low and almost identical for colonoscopy a n d b a r i u m enema. A similar score was given for the discomfort caused by bowel p r e p a r a t i o n with laxatives or electrolyte solutions. Thus, in most patients the degree of discomfort caused by u n s e d a t e d colonoscopy does not differ from t h a t of other diagnostic procedures t h a t p a t i e n t s are willing t o accept without prior sedation. F u r t h e r m o r e , as indicated by the continuous n o r m a l i z a t i o n of the initially elevated pulse rate, anxiety usually lessens d u r i n g the procedure irrespective of w h e t h e r or not sedatives are used. The question could be raised as to w h e t h e r the findings in the c u r r e n t investigation are r e l a t e d to p a t i e n t selection, procedure characteristics, or both. In fact, in a n o n r a n d o m i z e d s t u d y such as ours it is impossible to exclude with c e r t a i n t y a selection bias. For example, although we a t t e m p t e d to minimize p a t i e n t selection by enrolling only those patients into the s t u d y who h a d n e i t h e r prior bowel s u r g e r y nor prior experience with colon investigation, we c a n n o t rule out the possibility t h a t the referral p a t t e r n for colonoscopy and b a r i u m e n e m a was d e t e r m i n e d by the patients' clinical state. However, by excluding those in w h o m colonoscopy is most easily performed, 16 a p a t i e n t selection in favor of smooth a n d easy colonoscopies a p p e a r s unlikely. An issue t h a t m a y indeed have influenced the curr e n t results is the technique and p e r f o r m a n c e of colonoscopy. All procedures were done by two senior gastroenterologists with more t h a n 20 years' experience in endoscopy, and each of w h o m p e r f o r m at least 500 total colonoscopies each year. F u r t h e r m o r e , the availability of fluoroscopy for early s t r a i g h t e n i n g and telescoping of bowel loops as well as the presence of a second n u r s e for observing and comforting the p a t i e n t m a y h a v e m a d e a majo r contribution to the patients' favorable tolerance of the procedure. One could argue t h a t economic reasons will r a r e l y allow such conditions to be fulfilled. However, we believe t h a t the additional expense is greatly c o u n t e r b a l a n c e d by avoiding the recovery time from sedation and minimizing

180 G A S T R O I N T E S T I N A L E N D O S C O P Y

c a r d i o p u l m o n a r y complications. In fact, by avoiding sedation in the large majority of p a t i e n t s u n d e r g o i n g colonoscopy, we h a v e not experienced a n y cardiopulm o n a r y complications t h a t would h a v e led to hospitalization or a n y serious sequelae d u r i n g the last 15 years. In s u m m a r y , given the limitations of a n o n r a n d o m ized study, the c u r r e n t findings suggest t h a t unsed a t e d colonoscopy p e r f o r m e d by experienced edoscopists m a y not cause more discomfort t h a n b a r i u m enema. As suggested previously, s, 10 if patients undergoing this procedure can opt for e i t h e r i n t r a v e n o u s sedation or no premedication, 80% to 90% will prefer the latter. Given the fact t h a t most complications d u r i n g colonoscopy are r e l a t e d to the use of sedatives and narcotics, such observations raise the question as to w h e t h e r routine p r e m e d i c a t i o n for colonoscopy is serving the patients' needs. REFERENCES 1. Jaffe PE, Fennerty MB, Sampliner RE, Hixson LJ. Preventing hypoxemia during colonoscopy.A randomized controlled trial of supplemental oxygen. J Clin Gastroenterol 1992;14:114-6. 2. Dark DS, Campbell DR, Wesseling LJ. Arterial oxygen desaturation during gastrointestinal endoscopy.Am J Gastroenterol 1990;85:1317-20. 3. Hartke RH Jr, Gonzalez-Rothi RJ, Abbey NC. Midazolamassociated alterations in cardiorespiratory function during colonoscopy.Gastrointest Endosc 1989;35:232-8. 4. Kostash MA, Johnston R, Baily RJ, Konopad EM, Guthrie LP. Sedation for colonoscopy: a double-blind comparison of diazepam/meperidine, midazolam/fentanyl and propofol/fentanyl combinations. Can J Gastroenterol 1994;8:27-31. 5. Iber FL, Sutberry M, Gupta R, Kruss D. Evaluation of complications during and after conscioussedation for endoscopyusing pulse oximetry. Gastrointest Endosc 1993;39:620-5. 6. Herman LL, Kurtz RC, McKeeKJ, Sun M, Thaler HT, Winawer SJ. Risk factors associated with vasovagal reactions during colonoscopy.Gastrointest Endosc 1993;39:388-91. 7. Bianchi-Porro G, Lazzaroni M. Preparation, premedication and surveillance. Endoscopy 1992;24:1-8. 8. Nivatvongs S. How painful is colonoscopy?Gastrointest Endosc [abstract]. 1991;27:127. 9. Herman FN. Avoidance of sedation during colonoscopy.Dis Colon Rectum 1990;33:70-2. 10. Seow-Choen F, Leong APFK, Tsang C. Selective sedation for colonoscopy,Gastrointest Endosc 1994;40:661-4. 11. Eckardt VF, Kanzler G, Willems D. Same-day versus separateday sigmoidoscopyand double contrast barium enema: a randomized controlled study. Gastrointest Endosc 1989;35:512-5. 12. Welin S. Results of the Malm~ technique of colon examination. JAMA 1967;199:369-71. 13. Keeffe EB, O'Connor KW. 1989 A/S/G/E survey of endoscopic sedation and monitoring practices. Gastrointest Endosc 1990; 36:S13-$18. 14, Van Ness MM, Chobanian SJ, Winters C Jr, Diehl AM, Esposito RL, Cattau EL. A study ofpatient acceptance ofdoubleMcontrast barium enema and colonoscopy.Which procedure is preferred by patients? Arch Intern Med 1987;147:2175-6. 15. Steine S. Which hurts the most? A comparison of pain rating during double-contrast barium enema examination and colonoscopy. Radiology 1994;191:99-101. 16. Hull T, Church JM. Colonoscopy--how difficult, how painful? Surg Endosc 1994;8:784-7.

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