Secondary Logo

Journal Logo

In Response:

Ghai, Babita, MD, DNB; Ram, Jagat, MS; Makkar, Jeetinder Kaur, MD, DNB; Wig, Jyotsna, MD, FAMS; Kaushik, Sushmita, MS

Section Editor(s): Saidman, Lawrence

doi: 10.1213/ane.0b013e3181b2a830
Letters to the Editor: Letters & Announcements
Free

Department of Anaesthesia and Intensive Care; Post Graduate Institute of Medical Education and Research; Chandigarh, India (Ghai)

Department of Ophthalmology; Post Graduate Institute of Medical Education and Research; Chandigarh, India (Ram)

Department of Anaesthesia and Intensive Care; Post Graduate Institute of Medical Education and Research; Chandigarh, India; jeet1516@gmail.com (Makkar, Wig)

Department of Ophthalmology; Post Graduate Institute of Medical Education and Research; Chandigarh, India (Kaushik)

Back to Top | Article Outline

In Response:

In response to Dr. Fahy,1 we emphasize that as stated in our report,2 we strictly adhered to the research methodology of our institute including approval by our IRB and obtaining written informed consent from the patient’s guardians.

The debate over the use of sham procedures is not new and is far from settled.3,4 We agree that the Declaration of Helsinki states that “in medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society.” This statement, however, “confounds the ethics of clinical research and the ethics of clinical care. Clinical trials are not designed to promote the patient’s best interest; they are designed to answer valuable scientific questions.”5 Furthermore, reluctance to use sham interventions in any randomized controlled trial can be regarded as breach of ethics of clinical research in which the aim is to answer questions about groups of patients rather than provide personalized care.3

Boutron et al.6 systematically reviewed the Medline and Cochrane database for randomized control trials assessing nonpharmacological treatment with blinding in high-impact journals of 2004. They reported that 71 (58%) of 123 reports described the use of a sham procedure. If impact factor of the journal may be considered a predictor of methodological quality of the journal, this incidence of use of sham procedures for the purpose of blinding suggests that randomized double-blind sham-controlled trials have the methodological strength to produce valid results.

We compared the analgesic effect of subtenon block with the current standard practice of IV fentanyl in children undergoing cataract surgery.2 Because injection of saline/drug in subtenon space produces some amount of chemosis of the eye, sham subtenon block using saline was added in the control group to achieve double blinding. In other words, by examining the eye during surgery, the surgeon and the anesthesiologist can determine whether the block had been administered and unintended bias could have caused the anesthesiologist to use more analgesics intraoperatively in children not receiving a subtenon injection.

Risk differs with the type of sham procedure. Most of the common complications of subtenon block in adults are minor.7 No complication related to subtenon block in children have been reported to date.8 Also, in our study, no complications were attributed to the subtenon injection. Hence, we believe that the benefit achieved by scientifically valid methodology of our study outweighed the risks involved.

Babita Ghai, MD, DNB

Department of Anaesthesia and Intensive Care

Post Graduate Institute of Medical Education and Research

Chandigarh, India

Jagat Ram, MS

Department of Ophthalmology

Post Graduate Institute of Medical Education and Research

Chandigarh, India

Jeetinder Kaur Makkar, MD, DNB

Jyotsna Wig, MD, FAMS

Department of Anaesthesia and Intensive Care

Post Graduate Institute of Medical Education and Research

Chandigarh, India

jeet1516@gmail.com

Sushmita Kaushik, MS

Department of Ophthalmology

Post Graduate Institute of Medical Education and Research

Chandigarh, India

Back to Top | Article Outline

REFERENCES

1.Fahy CJ. Blind enough? Sham subtenons block in pediatric patients. Anesth Analg 2009;109:1349
2.Ghai B, Ram J, Makkar JK, Wig J, Kaushik S. Subtenon block compared to intravenous fentanyl for perioperative analgesia in pediatric cataract surgery. Anesth Analg 2009;108:1132–8
3.Miller FG, Kaptchuk TJ. Sham procedures and the ethics of clinical trials. J R Soc Med 2004;97:576–8
4.Wolf BR, Buckwalter JA. Randomized surgical trials and “sham” surgery: relevance to modern orthopaedics and minimally invasive surgery. Iowa Orthop J 2006;26:107–11
5.Cahana A, Romagnioli S. Not all placebos are the same: a debate on the ethics of placebo use in clinical trials versus clinical practice. J Anesth 2007;21:102–5
6.Boutron I, Guittet L, Estellat C, Moher D, Hróbjartsson A, Ravaud P. Reporting methods of blinding in randomized trials assessing nonpharmacological treatments. PLoS Med 2007;4:e61
7.Kumar CM, Williamson S, Manickam B. A review of sub-tenon’s block: current practice and recent development. Eur J Anaesthesiol 2005;22:567–77
8.Steib A, Karcenty A, Calache E, Franckhauser J, Dupeyron JP, Speeg-Schatz C. Effects of subtenon anesthesia combined with general anesthesia on perioperative analgesic requirements in pediatric strabismus surgery. Reg Anesth Pain Med 2005;30:478–83
© 2009 International Anesthesia Research Society