Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease

Congenital Heart Disease Clinical Trial

— PEACE-HYPNO  

Official title:

Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease: a Randomized Non-inferiority Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06373627
• Other study ID #: 2024-A00534-43
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2, 2024
• Est. completion date: May 3, 2025

Study information

• Verified date: April 2024
• Source: Fondation Hôpital Saint-Joseph
• Contact: Marie GERARD
• Phone: 0672510756
• Email: mariegerard[@]ymail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this prospective randomized controlled trial is to evaluate therapeutic hypnosis as a co-analgesia in thoracic drain removal in children with congenital heart disease. The hypothesis of this study is that therapeutic hypnosis combined with a minimal effective dose of medicated and inhaled sedation-analgesia is not inferior to higher doses of sedation-analgesia usually employed. This would make possible the reduction of cumulative dose of sedative medication and their side effects.

Description:

Pain and anxiety are common in children with congenital heart disease. They are at risk to develop impaired pain signal processing, and tolerance to opioids and benzodiazepines due to repeated exposure.

Removal of thoracic drains is a standard procedure following cardiac surgery in patients with congenital heart disease. This procedure is usually performed after multimodal sedation-analgesia (intraveinous and inhalation drugs). However, the drugs used (ketamine and midazolam) can have significant side-effects, such as respiratory and circulatory depression.

A few studies have shown the efficacy of therapeutic hypnosis and distractive methods in children, but with a low level of evidence, unlike in adults.

However, none of these studies has evaluated therapeutic hypnosis in children with congenital heart disease.

Hypnosis would be an additional way of better controlling procedural pain, without the side effects of medication. This would reduce the dose of analgesic drugs and improve the pain experience.

The aim of PEACE-Hypno is to evaluate therapeutic hypnosis as a co-analgesic way of thoracic drain removal in children with congenital heart disease.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: May 3, 2025
• Est. primary completion date: May 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• Patients aged ? 6 years and <18 years.

• Postoperative cardiac surgery patients with intrathoracic drains (pleural or mediastinal).

• Patients affiliated with or benefiting from a social security or similar scheme.

• Oral consent obtained from minor children

• Written consent from the minor's legal representatives

Exclusion Criteria:

• Psychomotor retardation, cognitive/psychiatric impairment preventing self-assessment of pain

• Absence of at least 1 legal representative of the minor child

• French not understood

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Heart Surgery
• Hypnosis
• Pain, Procedural
• Procedural Pain

Intervention

Other:
• Hypnosis
A hypnosis session takes place in 3 stages: An induction stage, where we move from an ordinary state of consciousness to a modified state of consciousness through dissociation. A work phase to deepen the hypnotic trance. This phase is fueled by the construction of suggestions and metaphors, analogous to those of the patient in pain. Finally, a return to the ordinary state of consciousness through re-association with the patient.

Drug:
• Conventional medications used for sedation-analgesia
MEOPA + intravenous ketamine (0.5 mg/kg) + intraveinous midazolam (50µg/kg)
• Medications used in addition to hypnosis
MEOPA + intravenous ketamine (0.3 mg/kg)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Hôpital Saint-Joseph

References & Publications (19)

Abdolkarimi B, Zareifar S, Golestani Eraghi M, Saleh F. Comparison Effect of Intravenous Ketamine with Pethidine for Analgesia and Sedation during Bone Marrow Procedures in Oncologic Children: A Randomized, Double-Blinded, Crossover Trial. Int J Hematol Oncol Stem Cell Res. 2016 Oct 1;10(4):206-211. — View Citation

Accardi MC, Milling LS. The effectiveness of hypnosis for reducing procedure-related pain in children and adolescents: a comprehensive methodological review. J Behav Med. 2009 Aug;32(4):328-39. doi: 10.1007/s10865-009-9207-6. Epub 2009 Mar 3. — View Citation

Birnie KA, Noel M, Chambers CT, Uman LS, Parker JA. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005179. doi: 10.1002/14651858.CD005179.pub4. — View Citation

Chanques G, Jaber S, Barbotte E, Verdier R, Henriette K, Lefrant JY, Eledjam JJ. [Validation of the french translated Richmond vigilance-agitation scale]. Ann Fr Anesth Reanim. 2006 Jul;25(7):696-701. doi: 10.1016/j.annfar.2006.02.017. Epub 2006 May 15. French. — View Citation

Chester SJ, Stockton K, De Young A, Kipping B, Tyack Z, Griffin B, Chester RL, Kimble RM. Effectiveness of medical hypnosis for pain reduction and faster wound healing in pediatric acute burn injury: study protocol for a randomized controlled trial. Trials. 2016 Apr 29;17(1):223. doi: 10.1186/s13063-016-1346-9. — View Citation

Chiaretti A, Ruggiero A, Barbi E, Pierri F, Maurizi P, Fantacci C, Bersani G, Riccardi R. Comparison of propofol versus propofol-ketamine combination in pediatric oncologic procedures performed by non-anesthesiologists. Pediatr Blood Cancer. 2011 Dec 15;57(7):1163-7. doi: 10.1002/pbc.23170. Epub 2011 May 16. — View Citation

Crellin D, Harrison D, Santamaria N, Babl FE. Comparison of the Psychometric Properties of the FLACC Scale, the MBPS and the Observer Applied Visual Analogue Scale Used to Assess Procedural Pain. J Pain Res. 2021 Mar 31;14:881-892. doi: 10.2147/JPR.S267839. eCollection 2021. — View Citation

Crellin DJ, Harrison D, Santamaria N, Babl FE. Systematic review of the Face, Legs, Activity, Cry and Consolability scale for assessing pain in infants and children: is it reliable, valid, and feasible for use? Pain. 2015 Nov;156(11):2132-2151. doi: 10.1097/j.pain.0000000000000305. — View Citation

Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, Hart RP, Dittus R. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001 Dec 5;286(21):2703-10. doi: 10.1001/jama.286.21.2703. — View Citation

Geagea D, Tyack Z, Kimble R, Polito V, Ayoub B, Terhune DB, Griffin B. Clinical Hypnosis for Procedural Pain and Distress in Children: A Scoping Review. Pain Med. 2023 Jun 1;24(6):661-702. doi: 10.1093/pm/pnac186. — View Citation

Krauss B, Green SM. Procedural sedation and analgesia in children. Lancet. 2006 Mar 4;367(9512):766-80. doi: 10.1016/S0140-6736(06)68230-5. — View Citation

Luo D, Wan X, Liu J, Tong T. Optimally estimating the sample mean from the sample size, median, mid-range, and/or mid-quartile range. Stat Methods Med Res. 2018 Jun;27(6):1785-1805. doi: 10.1177/0962280216669183. Epub 2016 Sep 27. — View Citation

Myles PS, Myles DB, Galagher W, Boyd D, Chew C, MacDonald N, Dennis A. Measuring acute postoperative pain using the visual analog scale: the minimal clinically important difference and patient acceptable symptom state. Br J Anaesth. 2017 Mar 1;118(3):424-429. doi: 10.1093/bja/aew466. — View Citation

Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012 Dec 26;308(24):2594-604. doi: 10.1001/jama.2012.87802. — View Citation

Rayala S, Kyander M, Haridass V, Palat G, Strom A, Wiebe T, Brun E, Segerlantz M. Low-dose Oral Ketamine as a Procedural Analgesia in Pediatric Cancer Patients Undergoing Bone Marrow Aspirations at a Resource-limited Cancer Hospital in India. Indian J Palliat Care. 2019 Oct-Dec;25(4):501-507. doi: 10.4103/IJPC.IJPC_110_19. — View Citation

Rodrigues VBM, Costa LR, Correa de Faria P. Parents' satisfaction with paediatric dental treatment under sedation: A cross-sectional study. Int J Paediatr Dent. 2021 May;31(3):337-343. doi: 10.1111/ipd.12661. Epub 2020 Jun 21. — View Citation

Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138. — View Citation

Staveski SL, Boulanger K, Erman L, Lin L, Almgren C, Journel C, Roth SJ, Golianu B. The Impact of Massage and Reading on Children's Pain and Anxiety After Cardiovascular Surgery: A Pilot Study. Pediatr Crit Care Med. 2018 Aug;19(8):725-732. doi: 10.1097/PCC.0000000000001615. — View Citation

Stinson JN, Kavanagh T, Yamada J, Gill N, Stevens B. Systematic review of the psychometric properties, interpretability and feasibility of self-report pain intensity measures for use in clinical trials in children and adolescents. Pain. 2006 Nov;125(1-2):143-57. doi: 10.1016/j.pain.2006.05.006. Epub 2006 Jun 13. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome : Pain evaluation by VAS self-assessment	The use of therapeutic hypnosis in addition to a minimal effective dose of intravenous and inhaled sedation-analgesia does not change level of pain generated by conventional sedation-analgesia during intrathoracic drain removal in children aged 6 to 18 years with congenital heart disease, self-assessed by VAS.	VAS will be measured 5 minutes before the start of the procedure (T0) and at the end of the procedure (T1) to assess the average pain intensity during drain removal.
Secondary	Hetero-assessment by FLACC scale of the pain during the intrathoracic drain removal	The use of therapeutic hypnosis in addition to a minimal effective dose of intravenous and inhaled sedation-analgesia generates non-inferior pain to that generated by conventional sedation-analgesia during intrathoracic drain removal in children aged 6-18 years with congenital heart disease, in hetero-assessment by FLACC by a blinded assigning arm assessor.	Scoring of the FLACC scale by the evaluator through study completion (up to1 year), blinded to the allocation arm, based on the video recorded during the procedure.
Secondary	Maximum heart rate	Comparison between the two groups of the maximum heart rate during intrathoracic drain removal, measured continuously on a monitor.	The maximum heart rate is measured during the intrathoracic drain removal, through the beginning to the end of procedure
Secondary	Cumulative doses of intravenous analgesics	Comparison between the two groups of the cumulative doses of Ketamine and Midazolam used during the procedure.	Cumulative doses of intravenous analgesics refer to drugs administered from the beginning to the end of the procedure.
Secondary	Respiratory depression	Comparison between the two groups of the number of episodes of respiratory depression corresponding to a respiratory rate of less than 10/min, measured continuously using the scope.	The number of respiratory depression is measured during the intrathoracic drain removal, through the beginning to the end of procedure.
Secondary	Parental satisfaction using Visual Analogic Scale (VAS)	Parents evaluate their satisfaction about the procedure, using a VAS self-assessment.	Parents evaluate their satisfaction the day after the procedure (D+1), with a minimal value of 0/10 (e.g no satisfaction), and a maximal value of 10/10 (maximal satisfaction)