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. 2013 Jan 1;3(4):e1. doi: 10.5037/jomr.2012.3401

Table 3C.

Critical Appraisal Table

Author Any side effects of treatment Null finding interpretation Important effects overlooked Comparison with previous literature Implications for practise
Castro et al. 2003 [38] Pain, Cardiovascular, Gatrointestinal, Haematological symptoms, Neurotoxicity, Hepatoxicity, Occular toxicity, Edema Severe side effects CDDP/epi gel group: 54.8% (34/62), Placebo gel group: 28% (7/25) Rejected 2 patients died- supposed to be related to treatment with CDDP/epi gel: 1 CVA, 1 fatal haemorrhage Conclusions similar to study by Werner et al. CDDP/epi gel is a good option for recurrence, but demands proper patient selection and skilful use

Georgiou et al. 2000 [39] Group A (thoracic catheter)
Group B (cervical catheter):
nausea and vomiting: A 50% (8/16);B 31% (4/13)
urinary retention: A 12.5% (2/16); B 0%
constipation: A 62% (10/62); B 38% (5/13)
purities: A 31% (5/16); B 15% (2/13)
Rejected More side effects in patients who received thoracic epidural morphine Agrees with the literature on the efficacy of epidural analgesia In cases of oral analgesia being ineffective epidural morphine is a good option with cervical being superior to thoracic.

Jovic et al. 2008 [40] Group A (Ketoprofen)
Group B (Metamizole):
nausea: A 10% (3/30); B 13.3%(4/30),
bleeding from wounds: A 10% (3/30); B 10% (3/30),
haematomas: A 10% (3/30); B 6.7% (2/30),
infections: A 10% (3/30); B 3.3% (1/30).
Rejected None No prior studies found Ketoprofen is an alternative to Metamizole for reducing pain postoperatively. More research is needed.

McNeely et al. 2004 [47] 10% (1/10) episode of nausea in PRET patient Rejected Varying period between surgery and exercise intervention Concurs with previous studies Exercise is an option post surgery to reduce pain

McNeely et al. 2008 [27] Pain in 3.7% (1/27) patient Rejected None Agrees with McNeely et al. 2004 (pilot study) Addition of PRET could be considered in Head and Neck cancer survivors, but more research with a less specific group needed

Pfister et al. 2010 [48] 27 minor events including: pain, bruising and bleeding Rejected None Comparable results with similar acupuncture trials on cancer pain. As acupuncture has only a few minor side effects, potential benefit outweighs risk.

Plantevin et al. 2007 [41] MNB with ropivacaine blood aspiration: A 26.3% (5/19);
Paraesthesia: A 31.6% (6/19);
No complications in GA group
Rejected No evaluation of block efficacy to maintain blinding. Patients must understand PCA First study to be carried out Beneficial for certain types of oropharyngeal surgery

Roussier et al. 2006 [42] Group A (PCA-Epid)
Group B (PCA-IV):
Nausea: A 5% (1/20); B 0%,
Vomiting: A 5% (1/20); B 4.5% (1/22),
Pruritus: A 5% (1/20); B 0%,
Urinary retention: A 0%; B 9.1% (2/22)
Rejected Patients must understand PCA Concurs with previous studies Dangers of epidural procedure outweigh benefits of increased pain control

Saxena et al. 1994 [43] Piroxicam group: 30% (6/20) experienced dry mouth
ASA group: 31.3% (5/16) experienced GI symptoms (e.g. nausea, sour eructations, vomiting)
Accepted 4 day follow-up First study to be carried out Piroxicam has less severe side effects and once daily dosing

Singhal et al. 2006 [44] 6.7% (2/30) patients on IV morphine were lethargic Rejected None First trial of type. Comparable trials on thoracic surgery yield similar results Implications limited as epidural risks outweigh benefits

Werner et al. 2002 [45] Group A (CDDP/epi gel)
Group B (Placebo gel): pain: A 33.3% (19/57); B 11.4% (4/35),
tachycardia: A 5.3% (3/57); B 0%, local cytotoxic effects,
headache: A 5.3% (3/57); B 0%,
nausea and vomiting: A 14% (8/57); B 0%,
hypomagnesemia: A 5.3% (3/57); B 0%,
local cytotoxic effects (erosion erythema, eschar, necrosis, swelling and ulceration): A 127 cases B 34 cases serious adverse event one in each of 8 patients:
anaemia, allergic reaction, haemorrhage, pallor, blindness, cardiac arrest (non-fatal), oedema, and swelling.
Rejected Subjective pain scoring by patients. (24/29) crossed over to receive active treatment after dropping out. Intention to treat maintained Concurs with previous studies Can be done as out patient Useful in palliation and intractable pain

Wittekindt et al. 2006 [46] Neck muscle weakness in 20% (2/10) patients in the BtxA high dose group Rejected No placebo group First study to investigate effect of different doses of BtxA. Previously reported that use of BtxA leads to pain reduction after neck dissection surgery. Low dose BtxA injections are a plausible option to reduce pain after neck dissection, however more studies are needed to determine dosage.

Yagi et al. 1997 [35] None mentioned Rejected N/A Agrees with literature on efficacy of Fentanyl and Piroxicam IV Fentanyl or pre-operative Piroxicam are good alternatives in the management of head and neck cancer pain postoperatively.

CVA = cerebrovaskular accident; CDDP/epi gel = intratumoral cisplatin/epinephrine injectable gel; PCA = patient controlled analgesia; PRET = progressive resistance exercise training; ASA = acetylsalicylic acid.