Comparision of pain relief after adenotonsilletomy in children with or without topical anaesthesia.
- Conditions
- Hypertrophy of tonsils with hypertrophy of adenoids,
- Registration Number
- CTRI/2020/09/027524
- Lead Sponsor
- AIR FORCE HOSPITAL
- Brief Summary
SYNOPSIS
Effect on post operative pain management in children with or without topical application of 0.5 % Bupivacaine in both tonsillar fossa and nasopharynx after adenotonsillectomy- A randomized control study
Dr. Jagadeeswaran V U- Department of ENT, 7 Air Force Hospital, Kanpur
Dr. H N Madhusudana- Department of Anaesthesia, 7 Air Force Hospital, Kanpur.
Dr Arun Mohan MV- Station Health Organization, Air Force Station Kanpur
INTRODUCTION
Adeno-tonsillectomy is considered to be the most common ENT surgery performed. Pain causes difficult to feed the children, so adequate post operative analgesia [1] is essential after Adeno-tonsillectomy. Various surgical techniques are used to perform the Adeno-tonsillecomy surgery but the most commonly used conventional surgical technique at our institution is curettage of adenoids and dissection and snare method of tonsils. Post operatively the children suffer severe throat pain for next three days. So in order to reduce post operative pain various tecchniques of perioperative local anaesthetics are used. There are three different methods of applying local anaesthetics [4].
1. Pre incisional peritonsillar infiltration
2. Post tonsillectomy wound infiltration
3. Post tonsillectomy packing with soaked gauze.
There are various local anaesthetic agents used for post operative pain relief in adenotonsillectomy like lignocaine and bupivacaine. In our study we will be using 0.5%bupivacaine soaked gauze of 6 ml in both tonsillar fossa and nasopharynx region. Bupivacaine is 3-4 times more potent than lignocaine and produce rapid and prolonged analgesia in the post operative period. Bupivacaine is an amino amide group of local anaesthetic agent. The drug half life is 8 hrs in children with effect duration of more than 24hrs. Mechanism of action of the drug is through specific blockage of sodium and potassium channels at the end of nerve fibres. The maximum allowable dosage of drug is 2 mg/kg body weight. In our study we had used 6ml of 0.5 % bupivacaine [2]. Since no serious adverse effect is reported for bupivacaine and given its half life, it will be usedin our study as a safe drug for peri-operative analgesia.There are various scales to measure the quality and intensity of pain. In earlier days most commonly used pain rating scale was visual analogue scale (VAS). Wong-Baker FACES pain rating scale is the pain scale most preferred by physician, parents and children. It is inexpensive and easy to use pain scale. The scales consist of 6 faces that range from no pain at all to the worst pain imaginable. The emotional faces ranges from smiling to grimacing. Children match their level of pain to a face on the scale. Children rating their pain on the Wong-Baker FACES pain rating scale [3] are better able to communicate their level of pain as opposed to surveys or other pain scale. The scale Wong-Baker FACES pain rating scale is modified and revised six face pain scale used to score pain rating in children as young as 3 yrs of age.
Aim of the study:
To study whether after topical application of 0.5 % Bupivacaine in both tonsillar fossa and nasopharynx after adenotonsillectomy results in significant reduction of post operative throat pain.
METHODS
The study will be conducted at our institution for duration of one year. The study will include Patients aged from 5-10yrs of both sex. The children will undergo Adeno-tonsillectomy through conventional surgical technique Curettage of adenoids and Dissection and Snare method of tonsils under General Anaesthesia.
Inclusion criteria:
1. Recurrent tonsillar infections.
2. Tonsillar hypertrophy with mouth breathing leading to obstructive symptoms.
Exclusion criteria:
1. Current upper respiratory system infection.
2. Any bleeding disorders.
The children will be examined clinically and planned for adenotonsillectomy. Children planned for surgery will undergo routine investigations and pre anaesthesia check up. Patients will be kept fasting for six hours prior to surgery. The anesthesiologist will be involved in anaesthesia management which will be standard and uniform for all children who undergo surgery. All the children will undergo oral endotracheal intubation and will be placed in Rose position.
The patients will be randomly divided into two groups.
Group 1 - Conventional surgical technique Curettage of adenoids and Dissection and Snare method of tonsils
Group 2 – After conventional surgical technique Curettage of adenoids and Dissection and Snare method of tonsils. Topical application of 0.5% Bupivacaine soaked gauze piece in 6 ml is placed in both tonsillar fossa and nasopharynx for duration of 5 minutes.
The patients in both groups will be extubated and placed in post tonsillectomy position. Post operatively all the children will be given syrup augmentin as antibiotics and syrup paracetomal as analgesia for 7 days as per body weight.
Wong – Baker FACES pain rating scale will be used to score the post operative pain of the children after surgery. The pain score will be done at 8hrs, 24hrs, day 3, and day 7 of post operative period. Once the child is able to feed soft diet the children are discharged. Day 3 and day 7 pain scoring will be done on follow at Otorhinolaryngology OPD.
Informed consent form will be taken from all parents of the children who underwent surgery.
METHOD OF ANALYSIS:
Data will be entered in MS Excel 2007 and will be analysed by epi info 7 version and statistical software SPSS 16.0 version. The patients will be allotted their respective groups by simple random sampling. The effect of local Bupivacaine on Pain score at different time duration has been analysed using Chi Square test and Mann Whitney U test. P value less than 0.05 will be considered significant.
REVIEW OF LITERATURE :
Study in India, 2005, Sona et al [5] concluded bupivacaine group was found to have significant lower pain score than the group where lignocaine was used. Bupivacaine group had pain relief for longer duration, well beyond the normal duration of pharmacological action of the drug. This is explained by the phenomenon of neuroplasticity which proposes that pre- emptive blockade of release of nociceptive neuromediators may contribute to the elimination of hyperexcitable state responsible for maintenance of post operative pain.
Most of the studies by Unal et al [6] and akoglu et al [7] the post operative pain assessment was done upto 24 hrs only. So we have planned to study for duration of 7 days post operative.
Grainger and colleagues [8] conducted a systematic review and meta-analysis regarding local anaesthetic use of local infiltration or topical application to reduce post operative pain after tonsillectomy. There was no significant difference in pain reduction.
In 2012 in Lahore, Hashmi et al [9] studied the impact of 0.5% bupivacaine use on post operative analgesia after tonsillectomy; the group that received bupivacaine clearly had significant reduction in post operative pain.
Study in Turkey, Tekelioglu [10] evaluated post operative pain reduction in 3 groups (Group A with bupivacaine, Group B with dexamathasone and Group C with placebo). Group A with bupivacaine showed reduction in post operative pain.
In 2019, Egypt, Pola et al [11] studied the effect of topical application of local anaesthesia in tonsillar fossa showed statistically significant reduction of post operative throat pain.
BIBLIOGRAPHY:
1. Cummings CW, Fredrickson JM, Harker LA. Otolaryngology head and neck surgery. 2010.
2. Manvi Mehta. A Randomised double blind clinical trial to compare the effects of preincisional infiltration of ropivacaine v/s bupivacaine on post tonsillectomy pain relief, JMSCR Vol/07/Issue/05/Page 589-599.
3. Merry A.F. et al. Randomised comparison between the combination of acetaminophen and ibuprofen and each constituent alone for analgesia following tonsillectomy in children. Can J Anaesth. 2013 Dec; 60(12):1180-9.
4. Stelter K, Hempel JM, Berghaus A, Andratschke M,Luebbers CW, Hagedorn H. Application methods of local anaesthetic infiltrations for postoperative pain relief in tonsillectomy: a prospective, randomised, double-blind, clinical trial. Eur Arch Otorhinolaryngol 2009 Oct; 266(10):1615-20.
5. Sona Chaturvedi, Domkondwar UG. A comparative study of topical analgesia with 4% lignocaine and 0.5% bupivacaine following tonsillectomy. Indian J. Anaesth. 2005; 49 (2) : 113 – 115.
6. Yusuf et al. Comparison of bupivacaine and ropivacaine on post-operative pain after tonsillectomy in paediatric patients. Int J Pediatr Otorhinolaryngology (2007) 71, 83-87.
7. Akoglu et al. Ropivacaine compared to bupivacaine for post tonsillectomy pain relief in children: A randomized controlled study. Int J Pediatr Otorhinolaryngology (2006) 70, 1169-1173.
8. Grainger J, Saravanappa N. Local anaesthetic for post-tonsillectomy pain: a systematic review and meta-analysis. Clin Otolaryngol 2008; 33:411–419.
9. Hashmi MA, Ahmed A, Aslam S, Mubeen M. Post-tonsillectomy pain and vomiting:role of pre-operative steroids. J Coll Physicians Surg Pak. 2012; 22(8) : 505 -9
10. Tekelioglu UY, Apuhan T, Akkaya A, Demirhan A, Yildiz I, Simsek T, et al. Comparison of topical tramadol and ketamine in pain treatment after tonsillectomy. Paediatr Anaesth. 2013; 23(6) : 496 -501
11. El Daly A, El Naby MA, Emad P. Effect on postoperative pain after topical application of local anesthetics in the tonsillar fossa after tonsillectomy. Egypt J Otolaryngol 2019; 35: 173-81.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 50
- Recurrent tonsillar infection 2.
- Tonsillar hypertrophy with mouth breathing leading to obstructive symptoms.
- Current respiratory tract infection.
- Bleeding disorders.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in level of post tonsillectomy pain score Pain score will be measured post operatively at 8 hrs, 24 hrs, Day 3 and Day 7
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
7 Air Force Hospital
🇮🇳Nagar, UTTAR PRADESH, India
7 Air Force Hospital🇮🇳Nagar, UTTAR PRADESH, IndiaDr Hrishikesh PisalPrincipal investigator9588478952hrishikesh.pisal@gmail.com